This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Individualized Repetitive Transcranial Magnetic Stimulation for Auditory Verbal Hallucinations (NCT05319080), a na na study. The primary outcome is Total Number of rTMS Sessions Completed.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05319080 |
| Phase | NA |
| Condition | Schizophrenia and Related Disorders |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 11 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Columbia University |
| Results posted | Yes |
2. Clinical Question
Population
The registry lists schizophrenia and related disorders as the condition. The study description focuses on people with schizophrenia who experience auditory verbal hallucinations—hearing voices that are not really there. Enrollment was 11 participants. The registry record does not report further eligibility details or describe the characteristics of the participants who enrolled.
Intervention
The intervention was individualized, MRI-guided repetitive transcranial magnetic stimulation (rTMS). The registry describes magnetic pulses delivered in a rapid sequence and a planned schedule of once-daily 20-minute sessions for 2 weeks, with weekends off. The primary outcome defines a session as 20 minutes of rTMS. The registry describes the planned treatment course as 10 sessions.
Comparator
There was no control group or randomized comparison. The study is recorded as a single-group trial with no masking. Participants’ session counts therefore describe treatment completion within this group; they do not provide a comparison with another treatment or with no treatment.
Primary question
The registered primary outcome asks how many rTMS sessions participants completed over 2 weeks. It is a treatment-delivery and completion measure, not a direct measure of change in hallucinations. The registry also lists symptom-rating outcomes, but results for those measures are not reported in the registry record. The posted primary result describes completion for some participants without giving a session count for every participant.
3. Trial Design
This was a pilot open-label study of individualized rTMS for patients with auditory verbal hallucinations. The registry records the phase as NA, allocation as NA, masking as none, and the model as single group. These entries describe a study without a randomized control group and without masking. The registry does not report a comparator arm, so the observations cannot be interpreted as a randomized treatment contrast.
Enrollment was 11. Columbia University is listed as the sponsor. The recorded start date is 2022-08-01, the primary completion date is 2023-03-31, and the status is terminated. The reason for termination is not reported in the registry record. No further details about recruitment, treatment delivery, or the circumstances of termination are reported.
The intervention description specifies MRI-guided rTMS sessions of 20 minutes, once daily for 2 weeks with weekends off. The registered primary outcome counts the total number of sessions completed during the 2-week timeframe. This design can describe whether participants completed the planned sessions, but, without a comparison group, it cannot separate the course of symptoms associated with the intervention from other influences.
The registry lists 13 outcome measures, including the primary session-count outcome and symptom-rating measures. The results presented for the primary outcome give completion details for some participants. Statistical analyses are not reported in the registry record. The protocol, sample-size justification, interim-analysis plan, and detailed statistical analysis plan are also not reported in the registry record. The available design information therefore supports a descriptive reading of treatment completion, not a confirmatory estimate of comparative efficacy.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Individualized Magnetic Resonance Imaging (MRI) Guided rTMS |
|---|---|
| STARTED | 11 |
| COMPLETED | 5 |
| NOT COMPLETED | 6 |
Reasons for not completing this period:
| Reason | Individualized Magnetic Resonance Imaging (MRI) Guided rTMS |
|---|---|
| Withdrawal by Subject | 2 |
| Physician Decision | 4 |
Analysis population for the primary outcome, as defined in the registry: Out of the 11 participants, 5 successfully finished all 10 treatment sessions, resulting in a combined total of 50 sessions. Additionally, two participants withdrew from the study early: one managed to complete 1 TMS treatment session, while the other completed 3 treatment sessions.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Individualized Magnetic Resonance Imaging (MRI) Guided rTMS |
|---|---|---|
| Participants analysed | 11 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 11 |
| Age, Categorical: >=65 years | Participants | 0 |
| Sex: Female, Male: Female | Participants | 4 |
| Sex: Female, Male: Male | Participants | 7 |
| Race/Ethnicity, Customized: Black or African American | Participants | 5 |
| Race/Ethnicity, Customized: White | Participants | 2 |
| Race/Ethnicity, Customized: Asian | Participants | 1 |
| Race/Ethnicity, Customized: Haitian | Participants | 1 |
| Race/Ethnicity, Customized: Hispanic | Participants | 1 |
| Race/Ethnicity, Customized: Unknown | Participants | 1 |
| Region of Enrollment: United States | participants | 11 |
6. Primary Endpoint
The registry lists the primary outcome as Total Number of rTMS Sessions Completed, measured over 2 weeks..
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | sessions |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the total number of rTMS sessions completed during 2 weeks. A session is defined as 20 minutes of rTMS, and the registry describes the outcome as a cumulative count of completed sessions. The planned course is described as 10 sessions.
A session count is a measure of treatment delivery and completion. It records how much of the scheduled stimulation participants received, rather than directly measuring whether auditory verbal hallucinations or other symptoms changed. Such a count can help characterize feasibility or adherence, although the registry record does not state why this endpoint was selected or identify it as a formal feasibility outcome.
The posted result says that 5 participants completed all 10 sessions, for a combined total of 50 sessions. It also reports that two participants withdrew early: one completed 1 session and the other completed 3 sessions. Session counts for all participants are not reported in the registry record. Because the reported endpoint is a count and the study has no comparator, it should be read as a description of treatment completion in this group, not as an estimate of symptom benefit or a between-group treatment effect.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The primary result is descriptive. Among the 11 enrolled participants, 5 completed all 10 planned sessions, accounting for a combined total of 50 sessions. The registry also reports early withdrawal by two participants: one completed 1 session and the other completed 3. These registry entries document treatment completion for the participants described, but the record does not give individual session counts for every participant or a complete distribution of the endpoint.
The count should not be mistaken for a symptom outcome. The registry lists changes in auditory hallucination, psychotic-symptom, positive-symptom, negative-symptom, and general-psychopathology scales as secondary outcomes. Results for those scales are not reported in the registry record. Consequently, the posted primary result does not establish whether symptom ratings changed during the study. It also does not describe the precision of any symptom change: no estimates, confidence intervals, or tests for those outcomes are reported in the registry record.
The design limits the questions that can be answered. This was a single-group, open-label study, with no randomized comparator and no masking. Session completion can be described within the enrolled group, but there is no control-group result against which to compare it. A difference in outcomes attributable to treatment cannot be estimated from a single group alone. Nor can the session count be used to infer that the intervention caused any symptom change.
No statistical analyses are reported in the registry record. There is no inferential estimate of the primary endpoint, no uncertainty interval, and no reported comparison or hypothesis test. The absence of such results means that the completion figures should be read as counts, not as evidence of a statistically established pattern. The registry record does not report a prespecified threshold for acceptable completion or a statistical criterion for judging the result.
Interpretation is further limited by incomplete endpoint detail. Although the record gives the total enrollment and partial completion information, it does not state the session counts for all participants. It also does not report how missing session data were handled or whether withdrawals were included in any analysis population. The posted information therefore supports a narrow conclusion: some participants completed the stated course, and the record identifies two early withdrawals with their session counts. It does not support a complete estimate of overall session completion or a treatment-effect conclusion.
9. Statistical Methods Explained
What does a count endpoint represent? The primary outcome is a cumulative count of completed rTMS sessions, with each session defined as 20 minutes. A count retains the discrete unit of interest: a participant either completed a recorded session or did not. Unlike a scale score, the endpoint does not itself measure the severity of hallucinations. It describes delivery of the intervention during the registered timeframe.
General statistical context: Count data can have distributions that differ from the symmetric patterns assumed by some standard methods. For example, participants may have different numbers of completed sessions, and counts may cluster near a planned course limit or include low values after early withdrawal. A statistical analysis should consider the outcome’s distribution and the study question before choosing a model. Over-dispersion matters when the observed variability in counts is greater than a model expects: uncertainty estimates from an unsuitable model may then be too small. These are general considerations, not methods reported for this trial.
The registry reports no statistical analyses for the posted outcomes. It does not identify a count model, a summary estimator beyond the cumulative count description, an uncertainty method, or a test for the primary endpoint. It is therefore not possible to attribute a particular statistical procedure to the investigators. The posted completion details can be described directly, but further estimates should not be inferred from them.
What can a single-group design estimate? A single-group study can report observed outcomes among enrolled participants. It does not include a randomized control group for estimating a contrast between treatment conditions. In this trial, the primary outcome describes completed sessions, and the registry provides no comparator data. The study therefore offers no randomized estimate of how session completion or symptoms would differ under another condition. The lack of masking is also recorded; the registry does not describe any steps to limit the potential influence of awareness of treatment on outcome assessment.
How should precision be understood? A confidence interval is a range of estimates compatible with the data and a statistical procedure; it communicates uncertainty around an estimate rather than guaranteeing that the true value lies in that range. No confidence interval for the primary session count or symptom outcomes is reported in the registry record. With only the reported counts, readers cannot assess precision in the form of an interval or determine the uncertainty around a group-level estimate.
What do planning illustrations mean? The registry record describes sample-size illustrations based on a stated fraction of an observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It also distinguishes illustrations for time-to-event outcomes from those for other outcomes. These are planning assumptions, not the trial’s own design justification and not observed power. The record does not report a sample-size justification for this single-group study. Because the study has no randomized two-arm comparison, the equal-allocation planning setup should not be mistaken for the trial’s actual design or for evidence that a comparison was conducted.
General power calculations concern the chance that a specified analysis would detect an assumed effect under stated conditions. They do not indicate whether an observed finding is true, and a planning calculation is not a substitute for reporting an estimate with its uncertainty. The registry’s description of planning illustrations does not supply a basis for claiming that the study was adequately powered, nor does it report an observed-power analysis. No sample-size values or effect estimates for such illustrations are reported in the registry record.
What is needed to interpret secondary outcomes? The registered secondary outcomes cover several symptom domains, measured with the AHRS, PSYRATS, SAPS, and PANSS instruments. For each outcome, interpretation would ordinarily depend on the reported measure, analysis population, timing, estimate of change, and uncertainty. Those results are not reported in the registry record. The outcome names alone do not establish that participants improved, worsened, or remained unchanged.
The analysis plan is not reported in the registry record. In particular, the record does not state how repeated measurements were modeled, how missing observations were handled, or whether adjustments for multiple outcomes were planned. These omissions matter because conclusions depend not only on which outcomes were registered, but also on how observations and uncertainty were analyzed. No model, test, or adjustment should be assumed in the absence of a reported method.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 13 outcome measures. The primary outcome is the total number of completed rTMS sessions. The secondary outcomes include changes in AHRS, PSYRATS auditory hallucination and delusion symptoms, SAPS hallucinations and delusions, and PANSS general psychopathology, positive symptoms, and negative symptoms. The presence of multiple outcomes raises a general multiplicity issue: when many statistical questions are tested, the chance of at least one apparently unusual result can increase. This is general statistical context, not a claim that the trial conducted multiple tests.
No outcome analyses are reported in the registry record, and a multiplicity strategy is not reported in the registry record. The record does not say whether outcomes were prioritized beyond the designated primary endpoint, whether testing was hierarchical, or whether any adjustment was planned. Since results for the symptom outcomes are also not reported, their direction, magnitude, and uncertainty cannot be evaluated.
The record gives some session-count information but does not report counts for every participant. A missing-data method, the reason for any unreported session counts, and the handling of withdrawals are not reported in the registry record. The analysis population is not reported in the registry record either; it is not stated whether all enrolled participants, only participants with recorded outcomes, or another group would be included in any analysis. These details are needed to understand the population represented by an estimate, but no such estimate is posted.
General statistical context: missing observations can affect both the amount of information available and the interpretation of a result. Their impact depends on why the data are missing and how the analysis handles them. No assumptions about missingness or imputation should be assigned to this trial based on the available record.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Individualized Magnetic Resonance Imaging (MRI) Guided rTMS | 0 | 11 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Individualized Magnetic Resonance Imaging (MRI) Guided rTMS | 0 of 11 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Individualized Magnetic Resonance Imaging (MRI) Guided rTMS | 4 of 11 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Individualized Magnetic Resonance Imaging (MRI) Guided rTMS |
|---|---|---|
| Headache | Nervous system disorders | 2 of 11 |
| Dizziness | Investigations | 2 of 11 |
| Facial pain | Nervous system disorders | 1 of 11 |
| Lightheadedness | Nervous system disorders | 1 of 11 |
| Neck discomfort | Nervous system disorders | 1 of 11 |
| Disorientation | Investigations | 1 of 11 |
| Back pain | Nervous system disorders | 1 of 11 |
The registry lists 11 participants at risk for serious adverse events and 0 affected. It lists 11 participants at risk for other adverse events and 4 affected. Deaths are recorded as 0, and no top serious-event terms are listed. These are participant-level counts in the adverse-event record; they should not be interpreted as event rates or as a complete description of event types.
The serious-event entry records no affected participants among those listed at risk. This is a statement about the events recorded in this trial, not proof that serious harms are impossible or that the intervention has no safety risks. The other-adverse-event count indicates that 4 participants were recorded as affected, but the record does not give the event types, severity, timing, or relationship to rTMS. It also does not describe how adverse events were assessed.
General statistical context: safety counts are more informative when readers can see event definitions, follow-up duration, exposure, and participant-level detail. Those details are not reported in the registry record beyond the listed counts and the treatment schedule. The single-group design also supplies no control-group safety comparison. The counts should therefore be read narrowly as the reported safety entries, without attributing causality or comparing risk between treatments.
12. What the Result Does, and Does Not, Mean
The posted result documents completed treatment sessions in a small, single-group pilot. It reports that 5 of the 11 participants completed all 10 sessions, corresponding to 50 sessions, and that two participants withdrew early after completing 1 and 3 sessions, respectively. This is information about how much treatment was recorded for the participants described.
It does not establish whether rTMS reduced auditory verbal hallucinations. The primary endpoint counts sessions, while the registered symptom measures would address symptom ratings. Those secondary results are not reported in the registry record. No statistical estimates or uncertainty intervals are reported for the primary outcome, and no analyses are reported for the outcomes overall.
The result also does not establish a comparative treatment effect. The trial had a single group, no randomized comparator, and no masking. Without a control group, the record cannot show how the observed completion or any unreported symptom course compares with what would have happened under another condition. The registry does not report a reason for the terminated status, so termination should not be interpreted as evidence of a particular outcome or safety concern.
Missing endpoint details limit even a descriptive assessment of overall completion: session counts for every participant are not reported. The registry entries support reporting the completed-session counts that are explicitly stated, but not filling gaps or deriving a complete group summary. The safety record reports 0 participants affected by serious adverse events, 4 affected by other adverse events, and 0 deaths; event details and causal assessments are not reported. Overall, the registry record offers limited descriptive information about treatment completion and safety entries, not a definitive assessment of symptom change, comparative efficacy, or the full safety profile.
13. Why This Trial Matters Statistically
This trial illustrates the distinction between a process measure and a clinical outcome. Counting completed sessions can describe whether an intervention was delivered as scheduled. It does not answer whether the targeted symptom changed. The registry makes that distinction important: the primary outcome is a session count, while symptom-rating scales are listed separately as secondary outcomes and their results are not reported.
It also illustrates the limits of interpreting a single-group study. The completion observations can be described for participants in the study, but the absence of a randomized comparator prevents a treatment contrast. The design therefore cannot, by itself, distinguish an intervention-associated change from other explanations for a change over time. That limitation applies even if a study has a clearly defined intervention and outcome.
The record further shows why outcome completeness and analysis details matter. Some session counts are reported, but not those for every participant. Without the full outcome distribution, a stated analysis population, and a missing-data approach, readers cannot assess how representative the reported completion details are of all enrolled participants. The lack of reported statistical analyses also means that precision and inferential uncertainty cannot be evaluated.
For biostatistical interpretation, the central lesson is to match each claim to the outcome and design actually reported. A count of completed sessions supports a description of treatment completion. It does not substitute for symptom results, a control group, or an uncertainty estimate. The record’s multiple registered outcomes also make transparent reporting of outcome prioritization and multiplicity methods relevant, although those methods are not reported in the registry record.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
Several limitations are specific to the information reported for this trial. The study is recorded as single group, open label, and without a randomized comparator. Its results therefore cannot provide a randomized comparison with another treatment or a control condition. The registry does not report masking procedures, and it does not report whether outcome assessors were independent of treatment delivery.
The primary outcome is session completion, not symptom change. Although the registry lists multiple symptom-rating outcomes, results for them are not reported in the registry record. The primary endpoint details also do not cover every enrolled participant: the record gives completion information for 5 participants who completed all 10 sessions and for two early withdrawals, but does not report session counts for all participants. A complete group-level summary cannot be reconstructed from those details.
The registry status is terminated, but the reason for termination is not reported in the registry record. The protocol, eligibility criteria beyond the listed condition, recruitment details, sample-size justification, interim analyses, analysis plan, missing-data procedures, and analysis population are not reported in the registry record. These omissions leave important design and analysis questions unresolved.
The safety information is also limited to counts. Event types, seriousness criteria, timing, duration, and attribution to the intervention are not reported in the registry record. With no comparator, the safety entries cannot support a between-group safety comparison. Taken together, these limitations constrain interpretation to the descriptive details recorded for treatment sessions and adverse events.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Individualized Repetitive Transcranial Magnetic Stimulation for Auditory Verbal Hallucinations — NCT05319080.
- Registry record last updated 2024-04-23; status last verified 2024-03.
- Results first posted 2024-04-23.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
The registry record describes a pilot open-label study of individualized MRI-guided rTMS for auditory verbal hallucinations in schizophrenia and related disorders. It records a single-group design, no masking, enrollment of 11, and a terminated status. The recorded start date is 2022-08-01 and primary completion date is 2023-03-31.
The primary outcome counts completed 20-minute rTMS sessions over 2 weeks. The posted result states that 5 participants completed all 10 sessions, for a combined total of 50 sessions; two participants withdrew early after completing 1 and 3 sessions. Session counts for all participants are not reported. The registry lists 13 outcome measures, but symptom results and statistical analyses are not reported in the registry record.
For safety, 0 participants are listed as affected by serious adverse events, 4 by other adverse events, and deaths are recorded as 0. Event details and a reason for termination are not reported in the registry record. The available findings are descriptive and do not establish a comparative treatment effect or symptom change.