Accelerated Intermittent Theta Burst Stimulation for Depressed Patients During the Covid-19 Pandemic

NCT ID: NCT04935489

Last Updated: 2023-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-12
• Study Completion Date: 2023-01-15

Brief Summary

Repetitive Transcranial Magnetic Stimulation (rTMS) using intermittent theta burst stimulation (iTBS) has been found to be a non inferior protocol to standard rTMS for the treatment of major depressive disorder. An accelerated course is of particular interest given the safety profile of the procedure and the potential to treat people more quickly making the treatment more accessible. This study aims to assess the feasibility and clinical outcomes of a high dose iTBS protocol in patients with depression in the context of unipolar or bipolar II disorder who are waiting for Electroconvulsive therapy (ECT) or rTMS due to degree of treatment resistance or severity of symptoms. This is a prospective, open-label, interventional pilot study wherein patients who have been diagnosed with major depressive disorder and referred to brain stimulation clinic, will be recruited for the treatment. Patients will be administered eight questionnaires before and after the treatment to assess the change in clinical outcomes.

Detailed Description

Participants will receive same stimulation protocol, however they will be given 6 times per day instead of once per day. Each Treatment will consist of a single iTBS treatment delivering 600 puses of iTBS (bursts of 3 pulses at 50 Hz, bursts repeated at 5 Hz, with a duy cycle of 2 seconds on, 8 seconds off, over 60 cycles and it takes about 3 minutes at a target of 90 to 120% of the subject's resting motor threshold. Treatment will be given through the device that is usually used, which is Magpro by Magventure, B70 Fluid-Cooled Coil .

Conditions

Treatment Resistant Depression

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients receiving accelerated rTMS

Group Type: EXPERIMENTAL

Intermittent Theta Burst Stimulation (form of repetitive transcranial magnetic stimulation) given in an accelerated form

Intervention Type: DEVICE

The intervention is used regularly for patients with treatment resistant depression, however, in this trial it will be given multiple times per day and over less days than the usual protocol

Interventions

Intermittent Theta Burst Stimulation (form of repetitive transcranial magnetic stimulation) given in an accelerated form

The intervention is used regularly for patients with treatment resistant depression, however, in this trial it will be given multiple times per day and over less days than the usual protocol

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 18 years and older
• Unipolar Depression or Bipolar II depression based on the MINI - no psychotic features
• Pass the TMS safety screen on the brain stimulation consultation template Voluntary and Competent to consent to treatment

Exclusion Criteria

• Have a MINI confirmed diagnosis of a substance use disorder within the last month
• Have a concomitant major unstable medical illness, cardiac pacemaker or implanted mediation pump
• Have a lifetime MINI diagnosis of bipolar I, or schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder.
• Have any significant neurological disorder or insult including but not limited to: any condition likely to be associated with increased intracranial pressure, space occupying brain lesion, any history of seizure except those therapeutically induced by ECT, or a febrile seizure of infancy or single seizure related to a known drug related event, cerebral aneurysm, or significant head trauma with loss of consciousness for greater than 5 minutes
• Have an intracranial implant (e.g. aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head (excluding the mouth) that cannot be safely removed.
• Currently taking more than lorazepam 2mg daily (or equivalent) or any dose of an anticonvulsant due to the potential to limit rTMS efficacy.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ontario Shores Centre for Mental Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Dr. Robyn Waxman

Head of Brain Stimulation Clinic

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robyn Waxman

Role: PRINCIPAL_INVESTIGATOR

Ontario Shores

Locations

Robyn

Whitby, Ontario, Canada

Countries

Canada

Other Identifiers

21-008-B

Identifier Type: -

Identifier Source: org_study_id