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| ID | Type | Description | Link |
|---|---|---|---|
| 5P20GM130452 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Butler Hospital | OTHER |
| University of Minnesota | OTHER |
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The study will examine whether inhibition of the pre-supplementary motor area (pSMA) using transcranial magnetic stimulation (TMS) normalizes activity in pSMA-connected circuits, improves response inhibition, and reduces compulsions in adolescents with OCD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TMS at visit 1, Sham at visit 2 | Other | At visit 1, participants will receive active TMS using continuous theta burst over the preSMA. At Visit 2, participants will receive sham (fake) TMS in the same location. |
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| Sham at visit 1, TMS at visit 2 | Other | At visit 2, participants will receive active TMS using continuous theta burst over the preSMA. At Visit 1, participants will receive sham (fake) TMS in the same location. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Magnetic Stimulation | Device | All teens will receive active TMS; they will be randomly assigned to receive active TMS at either visit 1 or visit 2 (order counterbalanced) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Response Time on Stop Trials of the Stop Signal Task | Computerized task, where shorter response time (in milliseconds) indicates better performance | Change from pre (within 1 hour before) to post (within 1 hour after) intervention |
| Change in Frontocentral P3 Amplitude on Electroencephalogram (EEG) | Electroencephalogram (EEG) measured amplitude on successful stop trials of the stop signal task (SST). Calculated by averaging the epochs of successful stop trials time-locked to the stop signal from the midline electrode (Cz). | Change from pre (within 1 hour before) to post (within 1 hour after) intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Self-report Symptom Question | Self-rated compulsions on a single-item 0-5 scale, where higher scores indicate more compulsions | post (within 1 hour after) intervention |
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Inclusion Criteria:
Exclusion Criteria:
• Medical conditions contraindicated for TMS or EEG, including history of intracranial pathology, increased intracranial pressure, epilepsy or seizures, traumatic brain injury, brain tumor, stroke, implanted medical devices, possible pregnancy (female of childbearing age not using effective contraception), or any other serious medical condition (note that medical history will be reviewed by a study physician prior to TMS administration)
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| Name | Affiliation | Role |
|---|---|---|
| Kristen Benito, PhD | Bradley Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emma Pendleton Bradley Hospital | Riverside | Rhode Island | 02915 | United States |
All enrolled participants were randomly assigned to a study arm.
Participants were recruited from a pediatric OCD specialty clinic between March 2022 and March 2023. Note that recruitment began in March 2022 before the first participant was formally enrolled on the study start date of April 1, 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | TMS at Visit 1, Sham at Visit 2 | At visit 1, participants will receive active TMS using continuous theta burst over the preSMA. At Visit 2, participants will receive sham (fake) TMS in the same location. Transcranial Magnetic Stimulation: All teens will receive active TMS; they will be randomly assigned to receive active TMS at either visit 1 or visit 2 (order counterbalanced) |
| FG001 | Sham at Visit 1, TMS at Visit 2 | At visit 2, participants will receive active TMS using continuous theta burst over the preSMA. At Visit 1, participants will receive sham (fake) TMS in the same location. Transcranial Magnetic Stimulation: All teens will receive active TMS; they will be randomly assigned to receive active TMS at either visit 1 or visit 2 (order counterbalanced) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Not different from information reported in participant flow
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| ID | Title | Description |
|---|---|---|
| BG000 | TMS at Visit 1, Sham at Visit 2 | At visit 1, participants will receive active TMS using continuous theta burst over the preSMA. At Visit 2, participants will receive sham (fake) TMS in the same location. Transcranial Magnetic Stimulation: All teens will receive active TMS; they will be randomly assigned to receive active TMS at either visit 1 or visit 2 (order counterbalanced) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Response Time on Stop Trials of the Stop Signal Task | Computerized task, where shorter response time (in milliseconds) indicates better performance | Does not include data from one participant who withdrew prior to completing the measure | Posted | Mean | Standard Deviation | milliseconds | Change from pre (within 1 hour before) to post (within 1 hour after) intervention |
|
Data were collected at one of two study visits that occurred over the course of two weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active TMS | Visits at which participants received active TMS using continuous theta burst over the preSMA. Note that all participants received both Sham and TMS; N for each "group" reflects the entire participant sample. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
This trial has a small sample size; results will need to be confirmed in a larger sample.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kristen Benito | Emma Pendleton Bradley Hospital | 401-432-1054 | kbenito@lifespan.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 19, 2024 | Nov 19, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 12, 2021 | Oct 9, 2021 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D009771 | Obsessive-Compulsive Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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Investigators will use a within-subject, counterbalanced design comparing TMS vs Sham in a brief 2-visit protocol
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| BG001 | Sham at Visit 1, TMS at Visit 2 | At visit 2, participants will receive active TMS using continuous theta burst over the preSMA. At Visit 1, participants will receive sham (fake) TMS in the same location. Transcranial Magnetic Stimulation: All teens will receive active TMS; they will be randomly assigned to receive active TMS at either visit 1 or visit 2 (order counterbalanced) |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Children's Yale Brown Obsessive Compulsive Scale (CYBOCS) | Clinician-rated measure of OCD symptom severity, total score on a 0 to 40 scale, where higher values indicate more severe symptoms. | Mean | Standard Deviation | units on a scale |
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Visits at which participants received sham (fake) TMS. Note that all participants received both Sham and TMS; N for each "group" reflects the entire participant sample.
|
|
| Primary | Change in Frontocentral P3 Amplitude on Electroencephalogram (EEG) | Electroencephalogram (EEG) measured amplitude on successful stop trials of the stop signal task (SST). Calculated by averaging the epochs of successful stop trials time-locked to the stop signal from the midline electrode (Cz). | Does not include data from two participants (one withdrew before completing the measure, one could not be analyzed due to error with EEG data capture) | Posted | Mean | Standard Deviation | microvolts (µV) | Change from pre (within 1 hour before) to post (within 1 hour after) intervention |
|
|
|
| Secondary | Self-report Symptom Question | Self-rated compulsions on a single-item 0-5 scale, where higher scores indicate more compulsions | Does not include one participant who withdrew before completing measure | Posted | Mean | Standard Deviation | units on a scale | post (within 1 hour after) intervention |
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| 0 |
| 6 |
| 0 |
| 6 |
| 1 |
| 6 |
| EG001 | Sham (Fake) TMS | Visits at which participants received sham (fake) TMS. Note that all participants received both Sham and TMS; N for each "group" reflects the entire participant sample. | 0 | 6 | 0 | 6 | 1 | 6 |
| Scalp discomfort | Nervous system disorders | Systematic Assessment |
|
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