Obsessive-Compulsive DisorderNCT05404360
Evaluation of the Long Term Efficacy and Durability of the BrainsWay Deep TMS in OCD Subjects
A study testing BrainsWay Deep TMS HAC/H7-Coil in people with Obsessive-Compulsive Disorder, run by Brainsway.
Trial summary
A Prospective Double Blind Randomized Controlled Trial to Evaluate the Long Term Efficacy and Durability of the BrainsWay Deep Transcranial Magnetic Stimulation (Deep TMS) in Obsessive-Compulsive Subjects Read more about this study
- Who is it for?
- Ages 18 to 88 years
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- BrainsWay Deep TMS HAC/H7-Coil
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- No sites listed yet
- Study dates
- Aug 2022to Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatients
- Males and females, 18-88 years of age
- Diagnosed as suffering from OCD according to the DSM-V.
- Subjects 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 entry and for the duration of the trial.
- 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 of ten sessions with a symptom checklist, hierarchy, with exposure and response prevention therapy.
Show all 12Show fewer
- 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.
- Must own a smartphone.
- All comorbid diagnoses have been stable for 3 months and anticipated to be stable for the 3 months treatment duration.
Who cannot join
- Subjects 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.
Show all 26Show fewer
- 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.
- 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
- Multiple sclerosis
- Substance use disorder within the past 6 months (except nicotine and caffeine).
- 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 eighteen months of baseline
- Treatment with any TMS in the past year.
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Prospective Double Blind Randomized Controlled Trial to Evaluate the Long Term Efficacy and Durability of the BrainsWay Deep Transcranial Magnetic Stimulation (Deep TMS) in Obsessive-Compulsive Subjects
A Prospective Double Blind Randomized Controlled Trial to Evaluate the Long Term Efficacy and Durability of the BrainsWay Deep Transcranial Magnetic Stimulation (Deep TMS) in Obsessive-Compulsive Subjects
Read the detailed description
The study is a randomized, double-blind, multi-center trial comparing active Deep TMS treatment to sham treatment over the course of the trial. The treatment phase will consist of 44 treatments over thirteen weeks. The acute treatment phase will consist five daily treatments over the course of six weeks, followed by twice weekly continuation treatments for seven weeks. Responders will be eligible to enter the durability phase. For assessment of durability, responders will be assessed quarterly for up to one year from the end of the treatment phase.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- BrainsWay Deep TMS HAC/H7-Coil, BrainsWay Deep TMS Sham Coil
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrainsWay Deep TMS HAC/H7-CoilDevice
Also called Active Treatment
The BrainsWay HAC/H7-Coil Deep TMS System is composed of four main components: an electromagnetic H7/HAC-Coil, TMS stimulator, cooling system and positioning arm.
BrainsWay Deep TMS Sham CoilDevice
The experimental system has two coils in the same helmet, a sham and active coil.
The sham coil has a similar acoustic artifact as the active coil and it administers a superficial stimulation to maintain blinding. The system assigns the active or sham coil based on the patient ID during the high frequency treatment.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | During the acute treatment phase, subjects will receive daily prefrontal Deep TMS treatment, 5 days a week for 6 consecutive weeks. Following the acute phase, patients will receive semi-weekly Deep TMS stimulation for an additional seven weeks. Treatment will include a total of 44 treatments over 13 weeks. Receives: Device: BrainsWay Deep TMS HAC/H7-Coil |
| Sham Control Group | Sham comparator | During the acute treatment phase, subjects will receive daily prefrontal sham treatment, 5 days a week for 6 consecutive weeks. Following the acute phase, patients will receive semi-weekly sham stimulation for an additional seven weeks. Treatment will include a total of 44 treatments over 13 weeks. Receives: Device: BrainsWay Deep TMS Sham Coil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Yale Brown Obsessive Compulsive Scale (YBOCS)
Change in YBOCS scores from baseline to the end of six weeks between the active Deep TMS and Sham treatment groups.
Scores on the YBOCS range from 0 (no Symptoms) to 40 (Extreme Symptoms).
Measured: 6 weeks
Yale Brown Obsessive Compulsive Scale (YBOCS)
Change in YBOCS scores from baseline to the end of thirteen weeks between the active Deep TMS and Sham treatment groups.
Scores on the YBOCS range from 0 (no Symptoms) to 40 (Extreme Symptoms).
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study startAug 2022 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The BrainsWay Deep TMS device is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD). The device technology is based on the application of deep brain TMS by means of repetitive pulse trains at a predetermined frequency.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brainsway
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05404360
- Sponsor's protocol ID
- CTP-OCD-02
- Status last verified
- Jul 2022
- First submitted
- 31 May 2022
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Double Blind Randomized Controlled Trial to Evaluate the Long Term Efficacy and Durability of the BrainsWay Deep Transcranial Magnetic Stimulation (Deep TMS) in Obsessive-Compulsive Subjects
- ClinicalTrials.gov ID
- NCT05404360
- Acronym / sponsor ID
- CTP-OCD-02
- Conditions
- Obsessive-Compulsive Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- BrainswayIndustry (pharma, biotech, devices)
- Study start
- Aug 2022 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 3 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Prospective Double Blind Randomized Controlled Trial to Evaluate the Long Term Efficacy and Durability of the BrainsWay Deep Transcranial Magnetic Stimulation (Deep TMS) in Obsessive-Compulsive Subjects
Detailed description
The study is a randomized, double-blind, multi-center trial comparing active Deep TMS treatment to sham treatment over the course of the trial. The treatment phase will consist of 44 treatments over thirteen weeks. The acute treatment phase will consist five daily treatments over the course of six weeks, followed by twice weekly continuation treatments for seven weeks. Responders will be eligible to enter the durability phase. For assessment of durability, responders will be assessed quarterly for up to one year from the end of the treatment phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- The BrainsWay Deep TMS device is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD). The device technology is based on the application of deep brain TMS by means of repetitive pulse trains at a predetermined frequency.
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Device: BrainsWay Deep TMS HAC/H7-CoilDuring the acute treatment phase, subjects will receive daily prefrontal Deep TMS treatment, 5 days a week for 6 consecutive weeks. Following the acute phase, patients will receive semi-weekly Deep TMS stimulation for an additional seven weeks. Treatment will include a total of 44 treatments over 13 weeks. |
| Sham Control Group | Sham comparator | Device: BrainsWay Deep TMS Sham CoilDuring the acute treatment phase, subjects will receive daily prefrontal sham treatment, 5 days a week for 6 consecutive weeks. Following the acute phase, patients will receive semi-weekly sham stimulation for an additional seven weeks. Treatment will include a total of 44 treatments over 13 weeks. |
Who may qualify
- Ages
- 18 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Outpatients
- Males and females, 18-88 years of age
- Diagnosed as suffering from OCD according to the DSM-V.
- Subjects 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 entry and for the duration of the trial.
Key exclusion criteria (26 listed)
- Subjects 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BrainsWay Deep TMS HAC/H7-CoilAlso: Active TreatmentThe BrainsWay HAC/H7-Coil Deep TMS System is composed of four main components: an electromagnetic H7/HAC-Coil, TMS stimulator, cooling system and positioning arm. | Device | Treatment Group |
| BrainsWay Deep TMS Sham CoilThe experimental system has two coils in the same helmet, a sham and active coil. The sham coil has a similar acoustic artifact as the active coil and it administers a superficial stimulation to maintain blinding. The system assigns the active or sham coil based on the patient ID during the high frequency treatment. | Device | Sham Control Group |
Primary outcome
Yale Brown Obsessive Compulsive Scale (YBOCS)
Time frame: 6 weeks
Change in YBOCS scores from baseline to the end of six weeks between the active Deep TMS and Sham treatment groups. Scores on the YBOCS range from 0 (no Symptoms) to 40 (Extreme Symptoms).
Yale Brown Obsessive Compulsive Scale (YBOCS)
Time frame: 13 weeks
Change in YBOCS scores from baseline to the end of thirteen weeks between the active Deep TMS and Sham treatment groups. Scores on the YBOCS range from 0 (no Symptoms) to 40 (Extreme Symptoms).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
Related trials for Obsessive-Compulsive Disorder
Enrolling by invitation
Family Accommodation Reduction in Adult Obsessive Compulsive Disorder
Obsessive - Compulsive Disorder, Family Accommodation
Not yet recruitingObservational study
Investigation of Obsessive-Compulsive Disorder in Patients With Elbow Epicondylitis
Lateral Epicondylitis, Medial Epicondylitis
Recruiting
Precision Analytic Research Methods in OCD
Obsessive Compulsive Disorder
Recruiting
Focused Ultrasound for Behavioral Health
Depression, Anxiety
Not yet recruiting
Linear Accelerator Radiosurgical Anterior Capsulotomy With Task-based fMRI Identification of PERSonalized and PrEdictiVE Biomarkers of REsponse in Treatment-Refractory Obsessive-Compulsive Disorder (PERSEVERE Trial)
Treatment-refractory Obsessive-compulsive Disorder (trOCD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing BrainsWay Deep TMS HAC/H7-Coil in people with Obsessive-Compulsive Disorder, run by Brainsway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahava Stein (97297670002, ahava@asteinrac.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Yale Brown Obsessive Compulsive Scale (YBOCS) (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2022.