Patient-oriented Randomized Pragmatic Feasibility Trial with RTMS in Depression and Anxiety

NCT05028738 | Recruiting

• 1 other identifier: H17-00161
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This trial compares intermittent theta-burst stimulation (iTBS) to low frequency repetitive transcranial magnetic stimulation (LFR) in regards to depression and anxiety outcomes in 100 patients with treatment resistant depression (TRD).

Conditions

Major Depressive Episode; Major Depressive Disorder

Keywords

Pragmatic; Patient-oriented research; TMS; Treatment-resistant depression; Transcranial Magnetic Stimulation; rTMS

Outcome Measures

Primary Outcomes (1)

• Depression severity

  Inventory of Depressive Symptoms (IDS-30-SR); Minimum value per question: 0; Maximum value per question: 3; Total minimum value: 0; Total maximum value: 84; Higher score means worse outcome.

  one week post treatment

Secondary Outcomes (2)

• Suicidal ideation

  one week post treatment

• Anxiety severity

  one week post treatment

Study Arms (2)

Intermittent Theta Burst Stimulation (iTBS)

ACTIVE COMPARATOR

iTBS to the L-DLPFC

Device: Repetitive Transcranial Magnetic Stimulation

Low Frequency Right (LFR)

ACTIVE COMPARATOR

1Hz stimulation to the R-DLPFC

Device: Repetitive Transcranial Magnetic Stimulation

Interventions

Repetitive Transcranial Magnetic Stimulation DEVICE

rTMS will employ the MagPro X100 stimulator equipped with the cool-B70 coil (MagVenture, Farum, Denmark). The dose will be a 120% resting motor threshold (rMT) in accordance to our latest trial using iTBS. Localization of the right and left DLPFC will follow the well-established Beam F3 procedure. Subjects will then undergo 30 sessions of rTMS, once daily on weekdays for 6 weeks. FDA-approved iTBS protocol will consist of bursts of 3 pulses at 50 Hz, bursts repeated at 5 Hz for 600 pulses total, 2 s on, 8 s off, for 3 min 9 sec, at 120% rMT. LFR will consist of 1 Hz stimulation consisting of a single train of 10min duration for 600 pulses total at 120% rMT.

Intermittent Theta Burst Stimulation (iTBS); Low Frequency Right (LFR)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• are outpatients;
• are voluntary and competent to consent to treatment;
• are ≥ 18 years;
• have a score ≥ 26 on the IDS-30-SR;
• have had no increase or initiation of any psychotropic medication in the 4 weeks prior to screening;
• able to adhere to the treatment schedule;
• pass the TMS adult safety screening (TASS) questionnaire

You may not qualify if:

• have active suicidal intent;
• are pregnant;
• have a lifetime diagnosis of schizophrenia, bipolar disorder type I, schizophreniform, schizoaffective disorder or presence of psychotic symptoms within last 3 months;
• have a concomitant major unstable medical illness;
• have any significant form of dementia or any history of epilepsy;
• have any 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;
• If participating in psychotherapy, must have been in stable treatment for at least 3 months prior to entry into the study, with no anticipation of change in the frequency of therapeutic sessions, or the therapeutic focus over the duration of the study;
• If they are taking psychotropic medication, be on a stable dose for 4 weeks before starting treatment, and no initiation of new regular psychotropic medication;
• have a clinically significant laboratory abnormality, in the opinion of the one of the principal investigators;
• have a non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview).

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Non-Invasive Neurostimulation Therapies (NINET) Laboratory, UBC Department of Psychiatry

Vancouver, British Columbia, V6T 2A1, Canada

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Fidel Vila-Rodriguez, MD, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Layton

CONTACT

604-822-7308; ninet.lab@ubc.ca

Michelle Avina, BSc

CONTACT

604-827-1361; michelle.avina@ubc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Single-masked (i.e. raters)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Two-arm, randomized feasibility trial

Study Record Dates

• First Submitted: August 7, 2021
• First Posted: August 31, 2021
• Study Start: October 11, 2021
• Primary Completion: July 1, 2025
• Study Completion: August 1, 2025
• Last Updated: December 20, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)