A Clinical Study on the Treatment of Obsessive Compulsive Disorder (OCD) with dTMS
Guohua Xia, MD, PhD
324 Madson Place,
Davis, CA 95618
This is a multicenteric study involving the use of a novel form of treatment methodology called deep Transcranial Magnetic Stimulation (dTMS) in the management of Obsessive Compulsive Disorder (OCD). This is a Non-Pharmaceutical, Non-Invasive form of treatment that we are investigating.
- Men and women 22-68 years of age.
- Subjects diagnosed as suffering from OCD according to the DSM-IV-TR.
- Subjects with at least moderate OCD, rating a YBOCS score of >20.
- Subjects are maintained on SSRI medication at at least a therapeutic dosage for at least 2 months prior to study entry and for the duration of the trial and/or subjects are maintained on psychotherapeutic behavioral intervention therapy (subjects undergoing CBT treatment must be in the maintenance stage (i.e., not during the assessment or skills acquisition or training stages).
- Subjects with negative responses on the Transcranial Magnetic Stimulation Safety Screening questionnaire (TASS).
- According to the treating physician the subject is compliant with taking medication, if applicable.
- Subject is capable and willing to provide informed consent.
- Subject is able to adhere to the treatment schedule.
- Subjects diagnosed according to the SCID I as suffering from any other Axis I diagnosis as the primary diagnosis.
- Subjects diagnosed according to the SCID II as suffering from severe Personality Disorder (excluding Obsessive Compulsive Personality Disorder) or hospitalized due to exacerbation related to borderline personality disorder.
- Present suicidal risk as assessed by the investigator using the Scale for Suicide Ideation (SSI), brief mental status exam and psychiatric interview or significant suicide risk based on HDRS-21 item 3 score of 3 or 4 or a history of attempted suicide in the past year.
- Subject has a history of epilepsy or seizure (EXCEPT those therapeutically induced by ECT) or history of such in first degree relatives.
- Subject has an increased risk of seizure for any reason, including prior diagnosis of increased intracranial pressure, or history of significant head trauma with loss of consciousness for greater than or equal to 5 minutes.
- Subject has a history of head injury necessitating cranial surgery or prolonged coma.
- Subject has a history of any metal in the head including the eyes and ears (outside the mouth).
- Subject has known history of any metallic particles in the eye, implanted cardiac pacemaker or any intracardiac lines, implanted neurostimulators, intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or implanted medical pumps.
- Subject has a history of significant hearing loss.
- Subjects with significant neurological disorder or insult including, but not limited to:
- Any condition likely to be associated with increased intracranial pressure
- Space occupying brain lesion
- History of cerebrovascular accident
- Transient ischemic attack within two years
- Cerebral aneurysm
- Parkinson’s disease
- Huntington’s chorea
- Multiple sclerosis
- Mini Mental State Exam score of less than or equal to 24
- Subject has a history of substance abuse including alcoholism within the past 6 months (except nicotine and caffeine).
- Subject is currently participating in another clinical study or enrolled in another clinical study within 30 days prior to this study.
- Subjects who suffer from an unstable physical, systemic and metabolic disorder such as unstabilized blood pressure or acute, unstable cardiac disease.
- Subject is currently on any antidepressant medication other than SSRIs.
- Subject is currently on Clomipramine
- Subject has had previous treatment with TMS
- Women who are breast-feeding
- Women who are pregnant or with suspected pregnancy
- Women of childbearing potential and not using a medically accepted form of contraception when engaging in sexual intercourse.
Adapted from http://clinicaltrials.gov/show/NCT01343732