Not provided
Not provided
Not provided
Not provided
PI has left Duke
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the effectiveness of repetitive TMS (rTMS) delivered simultaneously with elements of cognitive behavioral therapy/exposure-response prevention (CBT/ERP) in adult subjects (greater or equal to 18 years old) with obsessive-compulsive disorder (OCD). This is an open label study that involves standard of care for OCD (CBT) and an investigational treatment modality (TMS). The investigators will compare the Yale-Brown Obsessive Compulsive Scale (YBOCS) scores before and after treatment to quantify clinical improvement. The side effects from TMS include, but are not limited to, headache, seizure, and general pain. CBT has minimal side effects other than mental discomfort during the exposure sessions. For safety concerns, pregnant women and subjects with seizure-related history will be excluded as well as other indicated conditions in the details protocol.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rTMS and Cognitive Behavior Therapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial magnetic stimulation | Device |
| ||
| Cognitive behavioral therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Remission Rate, as Measured by Y-BOCS | Remission is defined as end-point Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score less than the value of 16. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response, as Measured by Y-BOCS | Complete response is defined as a reduction of Y-BOCS score greater than 35%. | 6 weeks |
| Partial Response Rate, as Measured by Y-BOCS | Partial response is defined as a reduction of greater than 25%. |
Not provided
Inclusion Criteria
Subjects must meet all of the following inclusion criteria to qualify for enrollment into the study:
All subjects will be 18 - 65 years of age.
Obsessive-compulsive disorder:
Subjects are willing and able to adhere to the intensive treatment schedule and all required study visits.
Exclusion Criteria
Subjects will be excluded from study participation if one of the following exclusion criteria applies:
Subjects are unable or unwilling to give informed consent.
No exclusion criteria for comorbid DSM diagnosis.
Subjects with a clinically defined neurological disorder that caused significant safety concern to receive TMS treatment, including, but not limited to:
Subjects with any of the following treatment histories:
Contraindication to receive TMS:
Women who are currently pregnant or not using a medically acceptable means of birth control and women who are breastfeeding.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Richard Weiner, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27705 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | rTMS and Cognitive Behavior Therapy | Transcranial magnetic stimulation Cognitive behavioral therapy |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Behavioral |
|
| 6 weeks |
| Percentage of Adverse Events | 6 weeks |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | rTMS and Cognitive Behavior Therapy | Transcranial magnetic stimulation Cognitive behavioral therapy |
| 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 | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||||||
| Gender | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | 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 | Remission Rate, as Measured by Y-BOCS | Remission is defined as end-point Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score less than the value of 16. | Posted | Number | percentage of participants | 6 weeks |
|
|
| |||||||||||||||||||||||||||
| Secondary | Complete Response, as Measured by Y-BOCS | Complete response is defined as a reduction of Y-BOCS score greater than 35%. | Posted | Number | percentage of participants | 6 weeks |
|
|
| |||||||||||||||||||||||||||
| Secondary | Partial Response Rate, as Measured by Y-BOCS | Partial response is defined as a reduction of greater than 25%. | Posted | Number | percentage of participants | 6 weeks |
|
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Adverse Events | Posted | Number | percentage of adverse events | 6 weeks |
|
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | rTMS and Cognitive Behavior Therapy | Transcranial magnetic stimulation Cognitive behavioral therapy | 0 | 2 | 0 | 2 |
Not provided
Not provided
This trial was terminated early leading to small numbers of subjects analyzed.
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richard Weiner, MD, PhD | Duke University | 919-681-8742 | weine002@duke.edu |
| ID | Term |
|---|---|
| D009771 | Obsessive-Compulsive Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
Not provided
Not provided
|
|
|