OCD
Conditions
Brief summary
The purpose of this study is to understand how cortical stimulation affects Obsessive-Compulsive Disorder (OCD) symptoms.
Detailed description
Obsessive-Compulsive Disorder (OCD) is a chronic and disabling disorder that costs the economy over $2 billion annually and represents a significant public health problem. This study aims to understand how cortical stimulation affects Obsessive-Compulsive Disorder
Interventions
Participants received 5 consecutive days of accelerated cTBSmod to the right frontal pole. Each cTBSmod session was comprised of 1800 pulses, delivered in a continuous train of 600 bursts. Each burst contained 3 pulses at 30 Hz, repeated at 6 Hz. Ten sessions were applied per day (18,000 pulses/day, hourly) (90,000 total pulses) using a Magventure Magpro X100. Stimulation was delivered at 90% resting motor threshold (depth corrected). Localite Neuronavigation System was used to position the TMS coil over the individualized stimulation target.
Sponsors
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-80 * Primary diagnosis of OCD * Sufficient severity of OCD symptoms * Capacity to provide informed consent
Exclusion criteria
* Psychiatric or medical conditions or medications that make participation unsafe * Pregnant or nursing females * Previous exposure to TMS or ECT * History of any implanted device or psychosurgery * Presence of metallic device or dental braces
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale. | Baseline and up to two weeks | Patients given YBOCS (Yale Brown Obsessive-Compulsive Scale), a gold standard measure of obsessions and compulsions. For the YBOCS the minimum units are 0 and Maximum units on the total scale are 40. The higher the number on the YBOCS, the more severe the symptoms. Response was defined as at least a 35% reduction on the YBOCS. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| rTMS Participants in the rTMS group will receive MagPro X100 by MagVenture (Active) cortical stimulation condition.
MagPro X100 by MagVenture: Participants in the rTMS group will receive MagPro X100 by MagVenture cortical stimulation condition. | 7 |
| Total | 7 |
Baseline characteristics
| Characteristic | rTMS |
|---|---|
| Age, Continuous | 40 years STANDARD_DEVIATION 15 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 5 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 7 |
| other Total, other adverse events | 4 / 7 |
| serious Total, serious adverse events | 0 / 7 |
Outcome results
Primary
Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale.
Patients given YBOCS (Yale Brown Obsessive-Compulsive Scale), a gold standard measure of obsessions and compulsions. For the YBOCS the minimum units are 0 and Maximum units on the total scale are 40. The higher the number on the YBOCS, the more severe the symptoms. Response was defined as at least a 35% reduction on the YBOCS.
Time frame: Baseline and up to two weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| rTMS | Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale. | 4 Participants |