Obsessive-Compulsive DisorderNCT04436952
Is There a New Gold Standard for the Treatment of Obsessive-Compulsive Disorder?
A study testing H7 coil, Cool D-B80 and Exposure Response Prevention (ERP) in people with Obsessive-Compulsive Disorder, run by University of Alberta at 1 site in Canada.
Trial summary
Obsessive Compulsive Disorder is a highly debilitating condition with a lifetime prevalence of 2%-3%, and a notable percentage of patients (40-60%) have a partial or no response to medications. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- H7 coil, Cool D-B80 and Exposure Response Prevention (ERP)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2020to Jul 2022
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatients ii. Men and women 18-70 years of age. iii. Patients diagnosed as suffering from OCD according to the BOCS and YBOCs. iv. Patients had an inadequate/intolerable response to SSRI, CBT (Exposure and Response Prevention) or both.
- Patient is capable and willing to provide informed consent, and their guardians is capable of providing informed consent.
- Patient is able to adhere to the treatment schedule.
Who cannot join
- Present suicidal risk is significant as assessed during the investigator's mental status exam and psychiatric interview.
- Patient has a history of epilepsy or seizure (EXCEPT those therapeutically induced by ECT) or history of such in first-degree relatives.
- Patient 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.
- Patient has a history of head injury necessitating cranial surgery or prolonged coma.
- Patient has ferromagnetic material in the head including the eyes and ears (outside the mouth) and body.
- Patient has a history of significant hearing loss. vii. Patients with significant neurological disorder or insult including, but not limited to:
Show all 19Show fewer
- 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
- Dementia
- Parkinson's disease
- Huntington's chorea
- Multiple sclerosis
- Mini Mental State Exam score of less than or equal to 24 (for adult participants) viii. Patient has a history of substance abuse including alcohol use disorder within the past 6 months (except nicotine and caffeine).
- Inadequate communication with the patient. x. Patient is currently participating in another clinical study or enrolled in another clinical study within 30 days prior to this study.
- Patients who suffer from an unstable physical, systemic and metabolic disorder such as unstable blood pressure or acute, unstable cardiac disease.
- Women who are pregnant or with suspected pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label Study to Compare and Evaluate the Efficacy of the Deep Transcranial Magnetic Stimulation With and Without Exposure and Response Prevention (ERP) to Repetitive Transcranial Magnetic Stimulation With and Without ERP to ERP.
Obsessive Compulsive Disorder is a highly debilitating condition with a lifetime prevalence of 2%-3%, and a notable percentage of patients (40-60%) have a partial or no response to medications. The present gold standard for the treatment of OCD is medications (Selective serotonin reuptake inhibitors (SSRIs) / Clomipramine) + Exposure and Response Prevention (ERP). There is a significant need for alternative novel methods of treatment. One of the novel methods of treating OCD is using magnetic stimulation which has already been successfully used in the treatment of depression. Treating OCD is difficult with regular superficial repetitive Transcranial Magnetic Stimulation (rTMS) hence the need for coils that targets deeper structures. Thus, we are comparing the efficacy of the two different coils from two different manufacturers plus using ERP in combination with the different coils.
- Deep Transcranial Magnetic Stimulation (DTMS) using BrainsWay H7 coil targets deeper structures such as medial prefrontal cortex. The H7 coil has already shown clear evidence in treating patients with OCD and has been approved by the FDA for clinical use.
- Repetitive Transcranial Magnetic Stimulation (rTMS) using MagVenture Cool D-B coil could also target the medial prefrontal cortex. Hence it might also be equally effective as the BrainsWay H7 coil in treating patients with OCD.
Read the detailed description
- Purpose
- The purpose of this study is to compare and evaluate the efficacy of repetitive Transcranial Magnetic Stimulation (rTMS) by MagVenture and Deep Transcranial Magnetic Stimulation (DTMS) by BrainsWay with and without the combination of active Exposure and Response Prevention (ERP) for the treatment of patients with OCD. ii. Hypothesis a) We hypothesize that the combination of TMS + active ERP will have a superior efficacy in the treatment of OCD. We also hypothesize that MagVenture cool D-B80 coil will be as effective as BrainsWay H7 coil in treating patients with OCD. iii. Justification
- The Prospective Multicenter Randomized Double-Blind Placebo-Controlled Trial by Carmi et al. (2019) had shown significant improvement in OCD symptoms by using the H7 coil and provocation of OCD symptoms before and during treatment.
- The study by Dunlop et al. (2016) has shown reduction in OCD symptom severity by using the Cool D-B80 Coil without provocation.
- There have been no head to head studies comparing the BrainsWay H7 coil and MagVenture Cool D-B80 coil using provocation methods for both coils.
- Also there have been no head to head studies comparing the gold standard treatment of medications + active ERP with medications + active ERP + TMS and medications + TMS. iv. Objectives
- The aim of the study is to evaluate and compare the efficacy of DTMS treatment and the rTMS treatment with and without the combination of active ERP in patients suffering from OCD, in conjunction with medications approved for OCD treatment.
- Research Method/Procedure
- Recruit 100 patients suffering from OCD who have been treated and currently on at least one SSRIs, SNRIs, clomipramine and at least one trial of CBT (Exposure and Response Prevention) had an inadequate response.
- Make a personalized provocation for each patient and using them during treatment
- The trial will consist of 3 phases:
- Pre-study screening and baseline assessment;
- Treatment trial period (8 weeks); and
- Follow-up (12 weeks).
- Clinical severity rating scales will be taken every other week and include: (Brief Obsessive-Compulsive Scale (BOCS), Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) , Beck's Depression Inventory (BDI), Clinical Global Impression Severity (CGI-S) and Clinical Global Impression Improvement (CGI-I). Safety evaluations will include adverse event monitoring, vital signs, and cognitive changes (Mini-Mental State Exam (MMSE)). All measures will be taken before treatment administration.
- Pre-Study Screening and Baseline Assessment
- Potential Patients will be given complete information describing the study treatment and their role in the trial, and they will be encouraged to ask any questions regarding the trial. The risks and requirements of this clinical research trial will be explained to each potential patient. Those volunteering to take part will read and sign the Informed Consent Form for participation in the clinical research trial before any trial-related procedures are performed.
- Upon obtaining the signed informed consent, inclusion and exclusion criteria will be reviewed to verify the patient's eligibility.
- Baseline data are defined as the data generated during the baseline visit before the first treatment Session.
- After the patients has been admitted into the study, they will be asked to undergo a fMRI and then randomly organized based on age and symptom severity into the 5 different groups.
- Comparing 5 groups of patients with OCD 1) Group 1 - 20 patients undergoing DTMS treatment using the H7 coil 2) Group 2 - 20 patients undergoing rTMS treatment using the cool D-B80 coil 3) Group 3 - 20 patients undergoing DTMS treatment using the H7 coil + ERP 4) Group 4 - 20 patients undergoing rTMS treatment using the cool D-B80 coil + ERP 5) Group 5 - 20 patients undergoing ERP only
- Treatment Trial period
- During the treatment phase the patients will either receive Group 1 - medial prefrontal cortex (mPFC) DTMS 5 days a week for 8 consecutive weeks = 40 Sessions 20 Hz at 100% MT, 2 s on 20 s off intertrain interval, 50 trains, 2000 stimuli per session. TMS will be done at active state by provocation Group 2 - dorsomedial prefrontal cortex (DMPFC) rTMS 5 days a week for 8 consecutive weeks = 40 sessions 10 Hz at 120% MT, 5 s on 10 s off intertrain interval, 60 trains, First 3000 pulses to the left DMPFC then 3000 pulses to the right DMPFC. TMS will be done at active state by provocation Group 3 - medial prefrontal cortex (mPFC) DTMS + ERP 5 days a week for 8 consecutive weeks = 40 sessions 20 Hz at 100% MT, 2 s on 20 s off intertrain interval, 50 trains, 2000 stimuli per session. TMS will be done at active state by provocation The ERP will be administered for 2 hours on week 1 and week 8 and for 1 hour on Weeks 2 to 7 for a total of 10 hours. Group 4 - dorsomedial prefrontal cortex (DMPFC) rTMS +ERP 5 days a week for 8 consecutive weeks = 40 sessions 10 Hz at 120% MT, 5 s on 10 s off intertrain interval, 60 trains, First 3000 pulses to the left DMPFC then 3000 pulses to the right DMPFC. TMS will be done at active state by provocation The ERP will be administered for 2 hours on week 1 and week 8 and for 1 hour on Weeks 2 to 7 for a total of 10 hours. Group 5 - ERP The ERP will be conducted for 2 hours on week 1 and week 8 and for 1 hour on Weeks 2 to 7 for a total of 10 hours.
- Prior to initiation and during each treatment of TMS, OCD symptoms will be provoked for each patient in an individual manner to activate the relevant brain circuitry. Targeted questions will be designed for each patient using external, internal or a combination of provocations and the degree of provocation on a Visual Analog Scale will be recorded. These may require adjustment as the patient improves.
- Study evaluations will be performed every week at the beginning of the next treatment week (from week 2), prior to the first or second (preferably second) treatment session of that week. Procedures to be performed at the 8-week visit will also be performed in case of Early Discontinuation of the study.
- Follow up period 1) All patients will be followed up at week 12. vi. Plan for Data Analysis
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- Primary Efficacy Variable
- The primary outcome measure is the BOCS and YBOCS severity rating scale. The primary efficacy endpoint is the change in BOCS and YBOCS severity score from baseline to the 8-week visit.
- Secondary Efficacy Variables
- Change from baseline to the 8-week visit in the Clinical Global Impression - Severity (CGI-S) and Improvement (CGI-I) scores.
- Change from baseline to the 12-week visit in the BOCS and YBOCS severity score.
- Change from baseline to the 12-week visit in the Clinical Global Impression - Severity (CGI-S) and Improvement (CGI-I) scores.
- Exploratory Efficacy Variables - Change from baseline to the 8 week and 12 weeks visit in the Beck's Depression Inventory score.
- fMRI changes before and after treatment and using fMRI to predict future response to TMS treatment (to identify responders and non-responders)
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- H7 coil, Cool D-B80, Exposure Response Prevention (ERP)
- Keywords
- Obsessive Compulsive Disorder, Transcranial Magnetic Stimulation, Exposure and Response Prevention
- 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.
H7 coilDevice
The H7 coil arm will receive a medial prefrontal cortex (mPFC) DTMS 5 days a week for 8 consecutive weeks = 40 Sessions 20 Hz at 100% MT, 2 s on 20 s off intertrain interval, 50 trains, 2000 stimuli per session.
Cool D-B80Device
The Cool D-B80 arm will receive dorsomedial prefrontal cortex (DMPFC) rTMS 5 days a week for 8 consecutive weeks = 40 sessions 10 Hz at 120% MT, 5 s on 10 s off intertrain interval, 60 trains, First 3000 pulses to the left DMPFC then 3000 pulses to the right DMPFC. TMS will be done at active state by provocation
Exposure Response Prevention (ERP)Behavioural
The ERP will be conducted for 2 hours on week 1 and week 8 and for 1 hour on Weeks 2 to 7 for a total of 10 hours
| Study group | Role | What they receive |
|---|---|---|
| H7 coil only | Experimental | patients undergoing DTMS treatment using the H7 coil Receives: Device: H7 coil |
| Cool D-B80 coil only | Active comparator | 20 patients undergoing rTMS treatment using the cool D-B80 coil Receives: Device: Cool D-B80 |
| DTMS treatment using the H7 coil + ERP | Active comparator | 20 patients undergoing DTMS treatment using the H7 coil + ERP Receives: Device: H7 coil; Behavioral: Exposure Response Prevention (ERP) |
| rTMS treatment using the cool D-B80 coil + ERP | Active comparator | 20 patients undergoing rTMS treatment using the cool D-B80 coil + ERP Receives: Device: Cool D-B80; Behavioral: Exposure Response Prevention (ERP) |
| ERP only | Active comparator | 20 patients undergoing ERP only Receives: Behavioral: Exposure Response Prevention (ERP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in the severity of OCD symptoms
- The primary outcome measure is the BOCS and YBOCS severity rating scale. The primary efficacy endpoint is the change in BOCS and YBOCS severity score from baseline to the 8-week visit.
Measured: 8 weeks
Secondary outcomes (1)
Clinical Global Impression - Severity (CGI-S) and Improvement (CGI-I) scores.
Change from baseline to the 8-week visit in the Clinical Global Impression - Severity (CGI-S) and Improvement (CGI-I) scores.
Change from baseline to the 12-week visit in the BOCS and YBOCS severity score. Change from baseline to the 12-week visit in the Clinical Global Impression - Severity (CGI-S) and Improvement (CGI-I) scores.
Measured: 8-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study startJul 2020 (estimated)
- Primary completionFeb 2021 (estimated)
- Study completionJul 2022 (estimated)
Why it stopped: Change in Protocol
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.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 1. Group 1 - 20 patients undergoing DTMS treatment using the H7 coil 2. Group 2 - 20 patients undergoing rTMS treatment using the cool D-B80 coil 3. Group 3 - 20 patients undergoing DTMS treatment using the H7 coil + ERP 4. Group 4 - 20 patients undergoing rTMS treatment using the cool D-B80 coil + ERP 5. Group 5 - 20 patients undergoing ERP only
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karthikeyan Ganapathy, MD, Principal investigator, Alberta Health Services/ Envision Mind Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04436952
- Sponsor's protocol ID
- ENV-OCD-2020-01
- Status last verified
- Jun 2020
- First submitted
- 23 May 2020
- Last updated
- 18 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Study to Compare and Evaluate the Efficacy of the Deep Transcranial Magnetic Stimulation With and Without Exposure and Response Prevention (ERP) to Repetitive Transcranial Magnetic Stimulation With and Without ERP to ERP.
- ClinicalTrials.gov ID
- NCT04436952
- Acronym / sponsor ID
- ENV-OCD-2020-01
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- Obsessive Compulsive Disorder, Transcranial Magnetic Stimulation, Exposure and Response Prevention
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Change in Protocol
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- Jul 2020 (estimated)
- Primary completion
- Feb 2021 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 18 Jun 2020 (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.
Obsessive Compulsive Disorder is a highly debilitating condition with a lifetime prevalence of 2%-3%, and a notable percentage of patients (40-60%) have a partial or no response to medications. The present gold standard for the treatment of OCD is medications (Selective serotonin reuptake inhibitors (SSRIs) / Clomipramine) + Exposure and Response Prevention (ERP). There is a significant need for alternative novel methods of treatment. One of the novel methods of treating OCD is using magnetic stimulation which has already been successfully used in the treatment of depression. Treating OCD is difficult with regular superficial repetitive Transcranial Magnetic Stimulation (rTMS) hence the need for coils that targets deeper structures. Thus, we are comparing the efficacy of the two different coils from two different manufacturers plus using ERP in combination with the different coils.
- Deep Transcranial Magnetic Stimulation (DTMS) using BrainsWay H7 coil targets deeper structures such as medial prefrontal cortex. The H7 coil has already shown clear evidence in treating patients with OCD and has been approved by the FDA for clinical use.
- Repetitive Transcranial Magnetic Stimulation (rTMS) using MagVenture Cool D-B coil could also target the medial prefrontal cortex. Hence it might also be equally effective as the BrainsWay H7 coil in treating patients with OCD.
Detailed description
- Purpose
- The purpose of this study is to compare and evaluate the efficacy of repetitive Transcranial Magnetic Stimulation (rTMS) by MagVenture and Deep Transcranial Magnetic Stimulation (DTMS) by BrainsWay with and without the combination of active Exposure and Response Prevention (ERP) for the treatment of patients with OCD. ii. Hypothesis a) We hypothesize that the combination of TMS + active ERP will have a superior efficacy in the treatment of OCD. We also hypothesize that MagVenture cool D-B80 coil will be as effective as BrainsWay H7 coil in treating patients with OCD. iii. Justification
- The Prospective Multicenter Randomized Double-Blind Placebo-Controlled Trial by Carmi et al. (2019) had shown significant improvement in OCD symptoms by using the H7 coil and provocation of OCD symptoms before and during treatment.
- The study by Dunlop et al. (2016) has shown reduction in OCD symptom severity by using the Cool D-B80 Coil without provocation.
- There have been no head to head studies comparing the BrainsWay H7 coil and MagVenture Cool D-B80 coil using provocation methods for both coils.
- Also there have been no head to head studies comparing the gold standard treatment of medications + active ERP with medications + active ERP + TMS and medications + TMS. iv. Objectives
- The aim of the study is to evaluate and compare the efficacy of DTMS treatment and the rTMS treatment with and without the combination of active ERP in patients suffering from OCD, in conjunction with medications approved for OCD treatment.
- Research Method/Procedure
- Recruit 100 patients suffering from OCD who have been treated and currently on at least one SSRIs, SNRIs, clomipramine and at least one trial of CBT (Exposure and Response Prevention) had an inadequate response.
- Make a personalized provocation for each patient and using them during treatment
- The trial will consist of 3 phases:
- Pre-study screening and baseline assessment;
- Treatment trial period (8 weeks); and
- Follow-up (12 weeks).
- Clinical severity rating scales will be taken every other week and include: (Brief Obsessive-Compulsive Scale (BOCS), Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) , Beck's Depression Inventory (BDI), Clinical Global Impression Severity (CGI-S) and Clinical Global Impression Improvement (CGI-I). Safety evaluations will include adverse event monitoring, vital signs, and cognitive changes (Mini-Mental State Exam (MMSE)). All measures will be taken before treatment administration.
- Pre-Study Screening and Baseline Assessment
- Potential Patients will be given complete information describing the study treatment and their role in the trial, and they will be encouraged to ask any questions regarding the trial. The risks and requirements of this clinical research trial will be explained to each potential patient. Those volunteering to take part will read and sign the Informed Consent Form for participation in the clinical research trial before any trial-related procedures are performed.
- Upon obtaining the signed informed consent, inclusion and exclusion criteria will be reviewed to verify the patient's eligibility.
- Baseline data are defined as the data generated during the baseline visit before the first treatment Session.
- After the patients has been admitted into the study, they will be asked to undergo a fMRI and then randomly organized based on age and symptom severity into the 5 different groups.
- Comparing 5 groups of patients with OCD 1) Group 1 - 20 patients undergoing DTMS treatment using the H7 coil 2) Group 2 - 20 patients undergoing rTMS treatment using the cool D-B80 coil 3) Group 3 - 20 patients undergoing DTMS treatment using the H7 coil + ERP 4) Group 4 - 20 patients undergoing rTMS treatment using the cool D-B80 coil + ERP 5) Group 5 - 20 patients undergoing ERP only
- Treatment Trial period
- During the treatment phase the patients will either receive Group 1 - medial prefrontal cortex (mPFC) DTMS 5 days a week for 8 consecutive weeks = 40 Sessions 20 Hz at 100% MT, 2 s on 20 s off intertrain interval, 50 trains, 2000 stimuli per session. TMS will be done at active state by provocation Group 2 - dorsomedial prefrontal cortex (DMPFC) rTMS 5 days a week for 8 consecutive weeks = 40 sessions 10 Hz at 120% MT, 5 s on 10 s off intertrain interval, 60 trains, First 3000 pulses to the left DMPFC then 3000 pulses to the right DMPFC. TMS will be done at active state by provocation Group 3 - medial prefrontal cortex (mPFC) DTMS + ERP 5 days a week for 8 consecutive weeks = 40 sessions 20 Hz at 100% MT, 2 s on 20 s off intertrain interval, 50 trains, 2000 stimuli per session. TMS will be done at active state by provocation The ERP will be administered for 2 hours on week 1 and week 8 and for 1 hour on Weeks 2 to 7 for a total of 10 hours. Group 4 - dorsomedial prefrontal cortex (DMPFC) rTMS +ERP 5 days a week for 8 consecutive weeks = 40 sessions 10 Hz at 120% MT, 5 s on 10 s off intertrain interval, 60 trains, First 3000 pulses to the left DMPFC then 3000 pulses to the right DMPFC. TMS will be done at active state by provocation The ERP will be administered for 2 hours on week 1 and week 8 and for 1 hour on Weeks 2 to 7 for a total of 10 hours. Group 5 - ERP The ERP will be conducted for 2 hours on week 1 and week 8 and for 1 hour on Weeks 2 to 7 for a total of 10 hours.
- Prior to initiation and during each treatment of TMS, OCD symptoms will be provoked for each patient in an individual manner to activate the relevant brain circuitry. Targeted questions will be designed for each patient using external, internal or a combination of provocations and the degree of provocation on a Visual Analog Scale will be recorded. These may require adjustment as the patient improves.
- Study evaluations will be performed every week at the beginning of the next treatment week (from week 2), prior to the first or second (preferably second) treatment session of that week. Procedures to be performed at the 8-week visit will also be performed in case of Early Discontinuation of the study.
- Follow up period 1) All patients will be followed up at week 12. vi. Plan for Data Analysis
<!-- -->
- Primary Efficacy Variable
- The primary outcome measure is the BOCS and YBOCS severity rating scale. The primary efficacy endpoint is the change in BOCS and YBOCS severity score from baseline to the 8-week visit.
- Secondary Efficacy Variables
- Change from baseline to the 8-week visit in the Clinical Global Impression - Severity (CGI-S) and Improvement (CGI-I) scores.
- Change from baseline to the 12-week visit in the BOCS and YBOCS severity score.
- Change from baseline to the 12-week visit in the Clinical Global Impression - Severity (CGI-S) and Improvement (CGI-I) scores.
- Exploratory Efficacy Variables - Change from baseline to the 8 week and 12 weeks visit in the Beck's Depression Inventory score.
- fMRI changes before and after treatment and using fMRI to predict future response to TMS treatment (to identify responders and non-responders)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- 1. Group 1 - 20 patients undergoing DTMS treatment using the H7 coil 2. Group 2 - 20 patients undergoing rTMS treatment using the cool D-B80 coil 3. Group 3 - 20 patients undergoing DTMS treatment using the H7 coil + ERP 4. Group 4 - 20 patients undergoing rTMS treatment using the cool D-B80 coil + ERP 5. Group 5 - 20 patients undergoing ERP only
| Arm | Type | Receives |
|---|---|---|
| H7 coil only | Experimental | Device: H7 coilpatients undergoing DTMS treatment using the H7 coil |
| Cool D-B80 coil only | Active comparator | Device: Cool D-B8020 patients undergoing rTMS treatment using the cool D-B80 coil |
| DTMS treatment using the H7 coil + ERP | Active comparator | Device: H7 coil, Behavioral: Exposure Response Prevention (ERP)20 patients undergoing DTMS treatment using the H7 coil + ERP |
| rTMS treatment using the cool D-B80 coil + ERP | Active comparator | Device: Cool D-B80, Behavioral: Exposure Response Prevention (ERP)20 patients undergoing rTMS treatment using the cool D-B80 coil + ERP |
| ERP only | Active comparator | Behavioral: Exposure Response Prevention (ERP)20 patients undergoing ERP only |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Outpatients ii. Men and women 18-70 years of age. iii. Patients diagnosed as suffering from OCD according to the BOCS and YBOCs. iv. Patients had an inadequate/intolerable response to SSRI, CBT (Exposure and Response Prevention) or both.
- Patient is capable and willing to provide informed consent, and their guardians is capable of providing informed consent.
- Patient is able to adhere to the treatment schedule.
Key exclusion criteria (19 listed)
- Present suicidal risk is significant as assessed during the investigator's mental status exam and psychiatric interview.
- Patient has a history of epilepsy or seizure (EXCEPT those therapeutically induced by ECT) or history of such in first-degree relatives.
- Patient 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.
- Patient has a history of head injury necessitating cranial surgery or prolonged coma.
- Patient has ferromagnetic material in the head including the eyes and ears (outside the mouth) and body.
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 |
|---|---|---|
| H7 coilThe H7 coil arm will receive a medial prefrontal cortex (mPFC) DTMS 5 days a week for 8 consecutive weeks = 40 Sessions 20 Hz at 100% MT, 2 s on 20 s off intertrain interval, 50 trains, 2000 stimuli per session. | Device | DTMS treatment using the H7 coil + ERP, H7 coil only |
| Cool D-B80The Cool D-B80 arm will receive dorsomedial prefrontal cortex (DMPFC) rTMS 5 days a week for 8 consecutive weeks = 40 sessions 10 Hz at 120% MT, 5 s on 10 s off intertrain interval, 60 trains, First 3000 pulses to the left DMPFC then 3000 pulses to the right DMPFC. TMS will be done at active state by provocation | Device | Cool D-B80 coil only, rTMS treatment using the cool D-B80 coil + ERP |
| Exposure Response Prevention (ERP)The ERP will be conducted for 2 hours on week 1 and week 8 and for 1 hour on Weeks 2 to 7 for a total of 10 hours | Behavioural | DTMS treatment using the H7 coil + ERP, ERP only, rTMS treatment using the cool D-B80 coil + ERP |
Primary outcome
Reduction in the severity of OCD symptoms
Time frame: 8 weeks
- The primary outcome measure is the BOCS and YBOCS severity rating scale. The primary efficacy endpoint is the change in BOCS and YBOCS severity score from baseline to the 8-week visit.
1 secondary outcome
Clinical Global Impression - Severity (CGI-S) and Improvement (CGI-I) scores.
Time frame: 8-12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2022.
- Individual participant dataSharing planned: No
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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.
Karthikeyan Ganapathy, MD principal investigator
Alberta Health Services/ Envision Mind Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing H7 coil, Cool D-B80 and Exposure Response Prevention (ERP) in people with Obsessive-Compulsive Disorder, run by University of Alberta at 1 site in Canada.
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 3 inclusion and 19 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: withdrawn, as of the sponsor's last update on 18 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in the severity of OCD symptoms (time frame: 8 weeks). 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 18 Jul 2022.