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New treatment option for Obsessive-Compulsive Disorder
Official title Accelerated Rotational Field Deep TMS for Treating OCD
ClinicalTrials.gov ID: NCT07116785
What this study is testing
- What it's testing
- A Prospective Double Blind Randomized Controlled Trial to Evaluate the Efficacy and Durability of the BrainsWay Rotational Field Deep Transcranial Magnetic Stimulation (Deep TMS) in Obsessive-Compulsive Subjects
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Outpatients
- Diagnosed as suffering from OCD according to the DSM-V.
- people with a YBOCS score of \>20.
- If on SRI, patient must be maintained on current dosages (with or without additional antidepressant or psychotropic augmentation for treatment of...
- If in CBT, must be in the maintenance stage (i.e., not receiving active training in exposure and response prevention, which is the core component of...
You likely can't join if
- people diagnosed as suffering from any other Axis I diagnosis as the primary diagnosis.
- Comorbid, secondary psychiatric diagnoses are unstable and are likely to require changes in therapeutic regimens even if OCD improves.
- Present suicidal risk as assessed by the investigator using the Columbia Suicide Severity Rating Scale, brief mental status exam and psychiatric...
- History of epilepsy or seizure (EXCEPT those therapeutically induced by ECT and febrile seizures in infancy).
- Increased risk of seizure for any reason, including prior diagnosis of increased intracranial pressure, or history of significant head trauma with...
- History of head injury necessitating cranial surgery or prolonged coma.
See the full eligibility criteria
Who can join
- Outpatients
- Diagnosed as suffering from OCD according to the DSM-V.
- people with a YBOCS score of \>20.
- If on SRI, patient must be maintained on current dosages (with or without additional antidepressant or psychotropic augmentation for treatment of OCD), at a stable therapeutic dosage for at least 2 months prior to study...
- If in CBT, must be in the maintenance stage (i.e., not receiving active training in exposure and response prevention, which is the core component of this treatment). CBT can be with teletherapy but must be for a minimum...
- Have negative or justified responses by the investigator to all questions listed 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 and assent.
- Willing and able to adhere to the treatment schedule.
- All comorbid diagnoses have been stable for 3 months and anticipated to be stable for the 3 months treatment duration.
What rules you out
- people diagnosed as suffering from any other Axis I diagnosis as the primary diagnosis.
- Comorbid, secondary psychiatric diagnoses are unstable and are likely to require changes in therapeutic regimens even if OCD improves.
- Present suicidal risk as assessed by the investigator using the Columbia Suicide Severity Rating Scale, brief mental status exam and psychiatric interview or a history of attempted suicide in the past year.
- History of epilepsy or seizure (EXCEPT those therapeutically induced by ECT and febrile seizures in infancy).
- 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.
- History of head injury necessitating cranial surgery or prolonged coma.
- History of any ferromagnetic of conductive material in the head including the eyes and ears (outside the mouth).
- Known history of any metallic particles in the eye, implanted neurostimulators, intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes).
- History of significant hearing loss.
- people with significant neurological disorder or insult
- Substance use disorder within the past 6 months (except nicotine and caffeine and based on the doctor's judgment).
- Currently participating in another therapeutic clinical study.
- Suffer from an unstable physical, systemic and metabolic disorder such as unstable blood pressure, unstable blood sugar, or acute, unstable cardiac disease.
- Subject on high doses of antidepressant or psychotropic medications, which are known to lower the seizure threshold. Subject is currently on Clomipramine.
- Significant possibility of death within eighteen months of baseline.
- Planned surgeries that will interrupt the study schedule within four months of baseline.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beersheba, Israel
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beersheba, Israel. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.