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 Theta Burst Stimulation for Alcohol Use Disorder (NCT06060496), a na na study. The primary outcome is Change in Penn Alcohol Craving Scale.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT06060496 |
| Phase | NA |
| Condition | Alcohol Use Disorder |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 8 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Gopalkumar Rakesh |
| Results posted | Yes |
2. Clinical Question
Population
Patients with alcohol use disorder. The registry record gives an enrollment of 8.
Intervention
Active continuous theta burst stimulation (cTBS), followed by sham cTBS in the same participants.
Comparator
Each participant’s sham cTBS session serves as a within-person comparison. The sequence is fixed: active first, then sham, with four weeks between sessions.
Primary question
How does the Penn Alcohol Craving Scale score change before and after two cTBS sessions?
The study is intended to examine the effects of two cTBS sessions given in a single day on resting-state functional MRI, alcohol-cue-related attentional bias, and alcohol craving. The primary outcome named in the registry is change in Penn Alcohol Craving Scale score. The record describes assessments before and after the two sessions, approximately 2 hours apart.
This is a within-participant question rather than a comparison between independently assigned groups. Each participant receives both active and sham stimulation, but all receive active stimulation first. The sham session is therefore not a randomized, like-for-like control arm: intervention type is linked to session order and elapsed time. The registry states that the interventions are given in a within-subject blinded fashion, but the masking field is listed as none and does not specify who, if anyone, was blinded.
The record describes the question and design, but it does not report the observed craving scores, changes, or statistical results. It therefore does not establish the size, direction, or precision of any difference between the sessions.
3. Trial Design
The registry describes a completed single-group study with an enrollment of 8 and no allocation type reported. It lists active cTBS and sham cTBS as device interventions. The one arm receives both interventions in a within-subject design: active cTBS first, followed by sham cTBS four weeks later. The record says this interval is intended to minimize carryover effects. It does not establish that carryover was absent.
The registry describes the treatment sequence as blinded within participants, while the overall masking field is NONE. It does not specify the people intended to be blinded, how blinding was maintained, or whether it was assessed. There is no randomized parallel-group comparison in the record, so the active and sham sessions should not be described as independently assigned treatment arms.
The primary completion date is 2024-04-17, the study start date is 2023-10-01, and the status is COMPLETED. The phase is listed as NA. The sponsor is Gopalkumar Rakesh. These registry entries describe the study record; they do not show whether every enrolled participant completed every assessment or was included in an analysis.
The primary outcome is change in Penn Alcohol Craving Scale score, measured before and after two cTBS sessions, approximately 2 hours. Resting State Functional Connectivity is listed as a secondary outcome. The registry states there are 3 outcome measures, but the record does not provide results for them or describe the other measures in the material.
Key operational details, including the statistical analysis plan, participant flow, handling of incomplete assessments, and analysis populations, are not reported in the registry record. The stated design can support a within-person comparison in principle, but the fixed order means a difference between sessions could also reflect order or time-related influences.
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 | Active cTBS and Sham cTBS |
|---|---|
| STARTED | 8 |
| COMPLETED | 4 |
| NOT COMPLETED | 4 |
Reasons for not completing this period:
| Reason | Active cTBS and Sham cTBS |
|---|---|
| Withdrawal by Subject | 2 |
| Lost to Follow-up | 2 |
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 | Active cTBS and Sham cTBS |
|---|---|---|
| Participants analysed | 8 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 8 |
| Age, Categorical: >=65 years | Participants | 0 |
| Age, Continuous | years | 41 (SD 11.7) |
| Sex: Female, Male: Female | Participants | 4 |
| Sex: Female, Male: Male | Participants | 4 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 8 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 1 |
| Race (NIH/OMB): White | Participants | 7 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Region of Enrollment: United States | Participants | 8 |
6. Primary Endpoint
The registry lists the primary outcome as Change in Penn Alcohol Craving Scale, measured over Before and after two cTBS sessions, approximately 2 hours.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | units on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is change in craving measured with the Penn Alcohol Craving Scale (PACS). The scale has five items, each rated from 1 to 6; the described total score ranges from 1 to 30. Higher scores indicate increased craving. The registry specifies a mean continuous outcome with standard deviation as the measure of dispersion.
Craving is a direct self-report measure of the experience the study aims to examine. Repeating the measure before and after the cTBS sessions allows researchers to describe whether scores change over the assessment period. The registry’s stated timeframe is before and after two cTBS sessions, approximately 2 hours. It does not give the precise schedule for each assessment beyond that description.
For a within-participant study, the central quantity would ordinarily be the change within each participant across the relevant assessment occasions, summarized across participants. Such a summary can describe the group’s average change, while its variability indicates how much individual changes differ. This is a general explanation, not a description of an analysis.
The registry record does not post the baseline or post-session scores, the mean change, its standard deviation, a confidence interval, or a test result. Consequently, the endpoint definition is available, but the magnitude and precision of the observed change are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record provides the study’s design and outcome definitions but no outcome analyses. In particular, it does not report PACS scores before or after stimulation, a mean change, variability, a confidence interval, or a p-value. There is therefore no posted estimate to interpret for the primary outcome. The record also does not report results for the listed secondary outcome, Resting State Functional Connectivity.
The enrollment was 8, but that figure alone does not tell readers how many participants completed each assessment or contributed data to an outcome analysis. The registry lists 0 analyses. This means the record does not supply an inferential result from which to assess the direction, size, or precision of a craving change. It is not appropriate to infer that there was no change, or that the sessions were equivalent, from the absence of a reported analysis.
The study’s one-arm, within-subject structure is important when reading any posted comparison. Participants receive active cTBS first and sham cTBS later, separated by four weeks. A difference between the sessions could reflect the intervention, but the fixed order also leaves session order and changes over time as possible explanations. The registry says the interval was chosen to minimize carryover effects; it does not report evidence that carryover was measured or eliminated. The design is not a randomized comparison of active and sham treatment groups.
Even if a numerical difference were posted elsewhere on the page, its statistical interpretation would depend on the analysis method, the participants included, and the uncertainty around the estimate. In general, a confidence interval conveys a range of values compatible with the data and the assumptions of the method. A narrow interval indicates greater precision than a wide interval, but neither an interval nor a p-value by itself resolves design limitations or establishes a causal effect. No such interval or test result is reported in the registry record.
The adverse-event entry should also be read separately from the craving endpoint. It records zero serious adverse events, zero other adverse events, and zero deaths in the listed group, with 4 participants at risk for each event category. These counts are safety entries, not evidence about the change in craving, and they do not establish what occurred among participants outside the recorded at-risk counts.
The sample-size section is a planning illustration, not a summary of observed power. The stated assumptions describe a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the target effect expressed relative to the observed effect. The trial itself is not a two-arm randomized study, and the registry record does not report the observed effect or the analyses needed to assess it. Any planning illustration should not be read as evidence that the study had a particular probability of detecting an effect.
9. Statistical Methods Explained
The primary outcome is continuous: it is a numerical scale score, and the registry identifies the summary as a mean with standard deviation. These summaries answer different questions. The mean describes the average score or average change in a group. The standard deviation describes how spread out participant scores or changes are around that mean. Neither is posted for the primary outcome in the registry record.
What would a within-person analysis describe?
In general, a within-person analysis compares measurements taken from the same participants under different conditions or at different times. Because each participant contributes observations in more than one condition, the analysis can account for the fact that observations from one person are related. This differs from treating the observations as if they came from unrelated groups.
For this study, a comparison of active and sham sessions would need to respect the repeated observations and the order in which they occurred. One possible general approach is to calculate an active-versus-sham contrast for each participant and summarize those contrasts. Another approach could model repeated observations directly. The registry record does not identify the method used, so neither approach should be attributed to this study as its actual analysis.
Why does order matter?
All participants receive active stimulation first and sham stimulation later. That fixed sequence means condition and session order are linked. In general, changes between sessions can reflect treatment, but can also reflect time, practice with measurement, changing circumstances, or lingering effects from an earlier session. The four-week gap is described as intended to minimize carryover effects; a gap alone does not demonstrate that carryover is absent. With no randomized order reported, the design cannot separate these explanations as cleanly as a randomized sequence could.
The registry’s description of blinded delivery may help reduce some expectations or assessment influences, depending on who was blinded and how. However, the masking field is NONE, and details of the blinding procedure are not reported in the registry record. Readers therefore cannot assess the intended protections or whether participants and assessors could distinguish the interventions.
How should uncertainty be understood?
In general, a confidence interval summarizes uncertainty around an estimate under a statistical model. It is useful to read the estimate and interval together: the estimate indicates the observed direction and size, while the interval shows how imprecisely that estimate is determined. A p-value, when reported, addresses compatibility with a specified statistical null model; it is not a measure of clinical importance and does not show the probability that a hypothesis is true.
These concepts require an estimated effect and its uncertainty. Neither a confidence interval nor a p-value for the PACS outcome is reported in the registry record. Because enrollment is 8, precision and sensitivity to individual observations would be important considerations in any analysis; the actual degree of precision cannot be evaluated without the outcome data and analysis results.
Why can variability matter?
The standard deviation describes variation among observations. In general, if participant-level changes vary substantially, the average change alone may not represent the range of individual patterns well. A model may also need to account for features of the outcome distribution. Over-dispersion, in general, means observed variability exceeds what a chosen model expects; ignoring it can make uncertainty appear smaller than it is. This is a general statistical consideration, not a reported finding in this study. The registry identifies a continuous mean outcome and standard deviation but does not report a distributional assessment or model diagnostics.
What do the planning illustrations mean?
The page includes sample-size planning illustrations based on assumptions stated in the registry material: a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and effects defined as a stated fraction of the observed effect. For continuous outcomes, the illustration is expressed as participants per arm for 80% power or another stated planning target where displayed. Such calculations are hypothetical planning quantities. They do not describe the number of participants actually analyzed, and they are not observed power.
These assumptions also do not match the design description exactly: the trial has one arm in which participants receive both active and sham cTBS, not two independently allocated arms. The registry record does not report the trial’s own sample-size justification. The planning section should therefore be read as an illustration under its stated assumptions, not as evidence that the study’s design or enrollment was chosen using that calculation.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 3 outcome measures and identifies PACS change as the primary outcome. Resting State Functional Connectivity is listed as a secondary outcome. The registry record does not identify the other outcome measures in the material, nor does it report results for any of them. It lists 0 analyses.
When a study examines multiple outcomes or makes several statistical comparisons, the chance of finding at least one apparently notable result can increase. In general, a prespecified analysis plan can clarify which outcomes and comparisons are primary and whether any adjustment for multiple testing is intended. No multiplicity strategy or detailed statistical plan is reported in the registry record. As a result, readers cannot determine how multiple outcomes, time points, or comparisons were handled.
The record does not report how missing observations were handled, whether any participants lacked endpoint measurements, or which analysis populations were used. It does not describe exclusions, imputation, or a method for accounting for incomplete repeated measurements. These details matter because an analysis limited to participants with complete measurements can differ from one that handles incomplete data using a stated model or imputation approach. This is a general methodological point; the actual missing-data pattern and handling are not reported in the registry record.
The enrollment of 8 should not be assumed to equal the number included in every outcome analysis. Without participant flow and analysis denominators, the extent of missingness and the population represented by any estimate cannot be assessed. No results are posted from which to judge whether missing data or multiplicity affected interpretation.
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 |
|---|---|---|---|
| cTBS and Sham cTBS | 0 | 4 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| cTBS and Sham cTBS | 0 of 4 |
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 |
|---|---|
| cTBS and Sham cTBS | 0 of 4 |
The registry reports safety counts for a group titled “cTBS and Sham cTBS.” It records 4 participants at risk for serious adverse events and 0 affected. For other adverse events, it records 4 at risk and 0 affected. Deaths are recorded as 0. The record lists no top serious-event terms.
These are event counts for the safety group, not outcome estimates for craving or functional connectivity. The at-risk counts are the denominators shown in the safety entry; they should not be replaced with the overall enrollment of 8. The record does not explain why the at-risk count is 4, how it relates to the enrolled participants, or whether the same participants contributed to both event categories.
A zero count means that no events of that category are recorded in this registry entry. It does not establish that no event could occur, and the small recorded at-risk group limits how broadly the counts can characterize safety. The registry does not provide additional event descriptions or a detailed safety-monitoring account in the material. These figures should be read as a summary of what is recorded, not as a guarantee of safety.
12. What the Result Does, and Does Not, Mean
This record describes a small, completed study of active and sham cTBS delivered to the same participants in a fixed sequence. It identifies a craving scale and other intended measurements, and records an enrollment of 8. It does not report the outcome values or analyses needed to determine what changes were observed.
The absence of a posted estimate is not evidence that the intervention had no effect, nor is it evidence of equivalence between active and sham sessions. Without scores, an estimated contrast, and uncertainty, readers cannot assess the direction, size, or precision of any outcome difference. The listed safety counts likewise describe only the registry’s recorded events and do not answer the primary craving question.
The design also limits what a session comparison could establish. Everyone received active cTBS before sham cTBS, so condition is linked to order. A difference could be associated with the intervention, but the record does not show how the analysis addressed the fixed sequence, possible time effects, or carryover. The four-week interval was intended to minimize carryover, but the record does not establish that it did so.
In general, statistical results are most informative when paired with clear definitions of the analysis population, methods, effect estimate, and uncertainty. Those details are not reported in the registry record. The planning illustrations on the page should not be interpreted as observed power or as proof that the study could detect a particular effect; they are calculations under stated assumptions, and the study’s own sample-size justification is not reported.
The record can therefore be used to understand the study question, its sequence, and its planned measurements. It does not support a conclusion about whether craving changed, whether active and sham sessions differed, or how precisely any difference was estimated.
13. Why This Trial Matters Statistically
The study is statistically notable because it uses a within-person design: participants receive both active and sham cTBS, allowing repeated measurements from the same people to be compared. In general, this structure can account for stable differences between individuals that complicate comparisons between separate groups. Its usefulness depends on appropriate handling of the repeated observations and a clear analysis plan.
Here, the intervention order is fixed, with active stimulation first and sham four weeks later. That feature makes the design especially important to interpret carefully. Treatment condition and period are intertwined, and a within-person comparison does not by itself remove time or order effects. The stated gap is intended to minimize carryover, but the record does not report evidence that it eliminated it.
The registry also illustrates why a well-defined endpoint and a posted result are separate things. It specifies the PACS scale, its score range, and the direction of interpretation, but does not report scores, estimates, or uncertainty. Without these, readers cannot judge the observed pattern or its precision. The sample-size illustrations are planning exercises and cannot substitute for outcome results.
Finally, this record highlights the value of transparent reporting of analysis populations, missing data, multiplicity, and blinding procedures. Those details are not reported in the registry record. Their absence makes it harder to assess how a potential within-person result would have been obtained and what conclusions it could support. These are statistical reporting considerations, not judgments about the study’s conduct.
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.
The principal limitation for interpretation is that the registry record contains no outcome analyses or numerical estimates. Although the primary outcome is defined, the observed PACS scores and changes are not reported. Readers therefore cannot evaluate the direction or magnitude of change, its variability, or its precision. The record also lists 0 analyses.
The enrollment is 8, but participant flow and endpoint-specific analysis counts are not reported in the registry record. It is unknown from this record whether all enrolled participants completed both sessions and assessments. The handling of missing data and the analysis populations are also not reported, limiting assessment of who is represented by any result that may appear elsewhere.
The study has one arm and a fixed intervention order: active cTBS first, then sham cTBS four weeks later. This is not a randomized, parallel active-versus-sham comparison. Order, period, and possible carryover could affect a session contrast. The four-week gap is intended to minimize carryover, but the registry does not provide evidence that it removed this concern.
Although the arm description says the sessions are given in a within-subject blinded fashion, the masking field is NONE. The record does not identify who was blinded or how blinding was implemented. It also does not report a detailed statistical plan, methods for handling multiple outcomes, or a sample-size justification for the trial’s own design.
The safety entry reports 4 participants at risk for each event category, while the overall enrollment is 8; the relationship between these counts is not explained. The record also does not provide detailed event terms. These limitations constrain interpretation of the registry entry and should not be filled in by assumptions.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Theta Burst Stimulation for Alcohol Use Disorder — NCT06060496.
- Registry record last updated 2025-05-06; status last verified 2025-04.
- Results first posted 2025-05-06.
- 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
NCT06060496 is a completed, single-group study titled “Theta Burst Stimulation for Alcohol Use Disorder,” sponsored by Gopalkumar Rakesh. The registry lists an enrollment of 8, a start date of 2023-10-01, and a primary completion date of 2024-04-17. Phase and allocation are listed as NA.
Participants in the one arm receive active cTBS followed by sham cTBS, with four weeks between sessions. The primary outcome is change in Penn Alcohol Craving Scale score, assessed before and after two sessions, approximately 2 hours. Resting State Functional Connectivity is listed as a secondary outcome.
The registry reports 3 outcome measures and 0 analyses. It does not report primary or secondary outcome results, a detailed statistical plan, or the trial’s sample-size justification. The safety entry records 0 serious adverse events, 0 other adverse events, and 0 deaths, with 4 participants at risk for each event category.