NCT04436952

Brief 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. 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.

  1. 1.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.
  2. 2.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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2020

Completed
26 days until next milestone

First Posted

Study publicly available on registry

June 18, 2020

Completed
13 days until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

July 18, 2022

Status Verified

June 1, 2020

Enrollment Period

7 months

First QC Date

May 23, 2020

Last Update Submit

July 14, 2022

Conditions

Obsessive-Compulsive Disorder

Keywords

Obsessive Compulsive DisorderTranscranial Magnetic StimulationExposure and Response Prevention

Outcome Measures

Primary Outcomes (1)

  • 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.

    8 weeks

Secondary Outcomes (1)

  • Clinical Global Impression - Severity (CGI-S) and Improvement (CGI-I) scores.

    8-12 weeks

Study Arms (5)

H7 coil only

EXPERIMENTAL

patients undergoing DTMS treatment using the H7 coil

Device: H7 coil

Cool D-B80 coil only

ACTIVE COMPARATOR

20 patients undergoing rTMS treatment using the cool D-B80 coil

Device: Cool D-B80

DTMS treatment using the H7 coil + ERP

ACTIVE COMPARATOR

20 patients undergoing DTMS treatment using the H7 coil + ERP

Device: H7 coilBehavioral: 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

Device: Cool D-B80Behavioral: Exposure Response Prevention (ERP)

ERP only

ACTIVE COMPARATOR

20 patients undergoing ERP only

Behavioral: Exposure Response Prevention (ERP)

Interventions

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.

DTMS treatment using the H7 coil + ERPH7 coil only
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

Cool D-B80 coil onlyrTMS treatment using the cool D-B80 coil + ERP
Exposure Response Prevention (ERP)BEHAVIORAL

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

DTMS treatment using the H7 coil + ERPERP onlyrTMS treatment using the cool D-B80 coil + ERP

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • i. 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.
  • v. Patient is capable and willing to provide informed consent, and their guardians is capable of providing informed consent.
  • vi. Patient is able to adhere to the treatment schedule.

You may not qualify if:

  • i. Present suicidal risk is significant as assessed during the investigator's mental status exam and psychiatric interview.
  • ii. Patient has a history of epilepsy or seizure (EXCEPT those therapeutically induced by ECT) or history of such in first-degree relatives.
  • iii. 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.
  • iv. Patient has a history of head injury necessitating cranial surgery or prolonged coma.
  • v. Patient has ferromagnetic material in the head including the eyes and ears (outside the mouth) and body.
  • vi. Patient has a history of significant hearing loss. vii. Patients 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
  • Dementia
  • Parkinson's disease
  • Huntington's chorea
  • Multiple sclerosis
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Envision Mind Care

Edmonton, Alberta, T6W 2Z8, Canada

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Study Officials

  • Karthikeyan Ganapathy, MD

    Alberta Health Services/ Envision Mind Care

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2020

First Posted

June 18, 2020

Study Start

July 1, 2020

Primary Completion

February 1, 2021

Study Completion

July 1, 2022

Last Updated

July 18, 2022

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)