Pilot Study of the Safety and Tolerability of L-DLPFC iTBS rTMS for MDD in MS

NCT04621708 | Unknown

• 1 other identifier: 1563
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this study is to investigate the safety and tolerability of intermittent Theta Burst (iTBS) repetitive transcranial magnetic stimulation (rTMS), its effectiveness in alleviating depressive symptoms as well as its effects on cognition. Although iTBS rTMS is approved for use, there have been no safety and tolerability evaluations of this form of rTMS in Multiple Sclerosis (MS).

Conditions

Multiple Sclerosis; Major Depressive Disorder

Keywords

MS; MDD

Outcome Measures

Primary Outcomes (1)

• Change in depressive symptoms

  The primary outcome measure will be the reduction in depressive symptoms as measured by the Hamilton Depression Rating Scale-17 at the end of the 4-week trial of iTBS rTMS. This will be measured as both a continuous variable (score on HAMD-17 at week 4 - score on HAMD-17 at week 0 pre-treatment) and a categorical one (i.e. the response rates of \>50% reduction from baseline HAMD-17 and remission rates defined as HAMD-17 \<7).

  Baseline and 4 weeks post-treatment

Secondary Outcomes (5)

• Change in anxiety and depressive symptoms

  Baseline and 4 weeks post-treatment

• Change in fatigue, severity and impact

  Baseline and 4 weeks post-treatment

• Change in Neuropsychological function

  Baseline and 4 weeks post-treatment

• Change in fatigue, severity and impact

  Baseline and 4 weeks post-treatment

• Change in Neuropsychological function

  Baseline and 4 weeks post-treatment

Study Arms (1)

Left DLPFC iTBS rTMS

EXPERIMENTAL

Device: Repetitive transcranial magnetic stimulation

Interventions

Repetitive transcranial magnetic stimulation DEVICE

Left DLPFC iTBS rTMS

Left DLPFC iTBS rTMS

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women ≥18 and ≤70 years of age, inclusive.
• History of MS confirmed by a neurologist.
• Patients who are able and willing to give consent and able to adhere to treatment schedule and attend study visits, as determined by study psychiatrist
• DSM-V diagnosis of Major Depressive Disorder (MDD)
• Moderate severity with a Hamilton Depression Rating Scale (HAMD) at least 16
• Patients have had no increase or initiation of any psychotropic medication in the 4 weeks prior to screening
• Pass the TMS safety screening questionnaire
• Women of childbearing potential must agree to use a barrier contraception method throughout the study.

You may not qualify if:

• Active substance abuse or dependence in the last three months, except nicotine
• Active suicidal intent
• Currently pregnant (as determined by history and serum HCG) or lactating.
• A diagnosis of Bipolar Disorder
• A history of past or current psychotic symptoms
• Diagnosis of obsessive-compulsive disorder, post-traumatic stress disorder (current or within the last year), assessed by a study investigator to be primary and causing greater impairment than MDD
• Having failed a course of ECT in the current episode or previous episode
• Previous trial of rTMS
• Personality disorder deemed to be primary pathology
• 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
• Clinically significant laboratory abnormality, in the opinion of the investigator
• Unstable medical illness
• Contraindication to rTMS, e.g. presence of cardiac pacemaker, intracranial implant, or metal in the cranium
• Currently on more than 2 mg of lorazepam or equivalent
• History of seizures, or currently on anticonvulsant for seizures

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis; Depressive Disorder, Major

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Central Study Contacts

Anusha Baskaran, PhD

CONTACT

416-480-6100; anusha.baskaran@sunnybrook.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Head, Harquail Centre for Neuromodulation

Model Details: This study is designed as an open-label pilot study

Study Record Dates

• First Submitted: October 21, 2020
• First Posted: November 9, 2020
• Study Start: April 30, 2020
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: March 15, 2023

Record last verified: 2023-03

Locations

CA (1)