Magnetic Brain Stimulation in the Treatment of Mild Cognitive Impairment

Not Applicable

Suspended

• Conditions: Mild Cognitive Impairment
• Interventions: Device: Repetitive Transcranial Magnetic Stimulation; Device: Sham Transcranial Magnetic Stimulation

• Registration Number: NCT02420522
• Lead Sponsor: University of Manitoba

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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-04-14
• Study First Submitted QC: 2015-04-14
• Study First Posted: 2015-04-20
• Study Start: 2015-09
• Primary Completion: 2017-12
• Status Verified: 2021-09
• Last Update Submitted: 2021-10-01
• Last Update Posted: 2021-10-08
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Active-first	Sham Transcranial Magnetic Stimulation	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.
Active-first	Repetitive Transcranial Magnetic Stimulation	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.
Sham-first	Repetitive Transcranial Magnetic Stimulation	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.
Full-course Active	Repetitive Transcranial Magnetic Stimulation	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.
Sham-first	Sham Transcranial Magnetic Stimulation	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.

Primary Outcome Measures

Name	Time	Method
Cognitive changes	Three weeks	Cognitive changes will be monitored through the administration of a number of pencil-and-paper and computer-based tasks that will be performed before and after each treatment week.

Trial Locations

Locations (1)

St Boniface Hospital; 🇨🇦 Winnipeg, Manitoba, Canada