Magnetic Brain Stimulation in the Treatment of Mild Cognitive Impairment

NCT ID: NCT02420522

Last Updated: 2021-10-08

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2021-12-31

Brief Summary

This is a pilot study to test the efficacy of repetitive transcranial magnetic stimulation (rTMS) on cognitive improvement in individuals with mild cognitive impairment (MCI). The main objective of this study is to investigate the ability of rTMS to produce cognitive improvement in individuals with MCI. A secondary objective is to determine whether individuals with MCI following mild brain trauma respond differently to rTMS treatment compared to individuals with non-trauma related MCI.

Participants will undergo both active and sham (placebo) rTMS treatment. Cognitive and psychological assessments will be administered before and after each week of rTMS therapy, for both active and sham conditions. Cognitive testing will include verbal, semantic, logic, visual, conceptual, and memory tasks.

Detailed Description

This is an open-label pilot study to test the efficacy of repetitive transcranial magnetic stimulation (rTMS) on cognitive improvement in individuals with mild cognitive impairment (MCI). 16 patients with trauma-related MCI and 16 patients with non-trauma-related MCI will be recruited. All patients will undergo one week of active rTMS stimulation and one week of sham stimulation, separated by at least one week. Each treatment week will consist of five consecutive daily stimulation sessions. The order of active versus sham treatment sessions will be counterbalanced across subjects within each group (i.e., half of the subjects in each group will receive active stimulation first and half will receive sham first). Cognitive and psychological assessments will be administered before and after each week of rTMS therapy, for both active and sham conditions.

Additional participants (n=32; 16 without TBI) will be recruited who are receiving a full course (30 sessions) of active rTMS treatment (without a sham intervention). These participants will complete the same cognitive testing as the sham-crossover group at three time-points: pre-treatment, mid-treatment (after session 16), and post-treatment (after session 30).

Conditions

Mild Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Active-first

Participants randomly assigned to this arm will receive one week of active Repetitive Transcranial Magnetic Stimulation prior to one week of Sham Transcranial Magnetic Stimulation, separated by at least one week.

Group Type: EXPERIMENTAL

Repetitive Transcranial Magnetic Stimulation

Intervention Type: DEVICE

A non-invasive method of brain stimulation.

Sham Transcranial Magnetic Stimulation

Intervention Type: DEVICE

A device designed to look, sound, and feel like a real magnetic stimulation coil without actually stimulating the brain.

Sham-first

Participants randomly assigned to this arm will receive one week of Sham Transcranial Magnetic Stimulation prior to one week of active Repetitive Transcranial Magnetic Stimulation, separated by at least one week.

Group Type: EXPERIMENTAL

Repetitive Transcranial Magnetic Stimulation

Intervention Type: DEVICE

A non-invasive method of brain stimulation.

Sham Transcranial Magnetic Stimulation

Intervention Type: DEVICE

A device designed to look, sound, and feel like a real magnetic stimulation coil without actually stimulating the brain.

Full-course Active

Participants in this arm will receive three weeks (30 session, twice-daily) of active Repetitive Transcranial Magnetic Stimulation. This arm will not involve random assignment.

Group Type: ACTIVE_COMPARATOR

Repetitive Transcranial Magnetic Stimulation

Intervention Type: DEVICE

A non-invasive method of brain stimulation.

Interventions

Repetitive Transcranial Magnetic Stimulation

A non-invasive method of brain stimulation.

Intervention Type: DEVICE

Sham Transcranial Magnetic Stimulation

A device designed to look, sound, and feel like a real magnetic stimulation coil without actually stimulating the brain.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Adults presenting with mild cognitive impairment (trauma and non-trauma related)

Exclusion Criteria

• History of a psychotic episode
• History of neurological illness
• Active alcohol or substance abuse
• History of seizure disorder
• Currently pregnant

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Manitoba

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mandana Modirrousta, MD PhD FRCPC

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Locations

St Boniface Hospital

Winnipeg, Manitoba, Canada

Countries

Canada

Other Identifiers

B2014:134

Identifier Type: -

Identifier Source: org_study_id