NCT02420522

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 20, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

October 8, 2021

Status Verified

September 1, 2021

Enrollment Period

2.3 years

First QC Date

April 14, 2015

Last Update Submit

October 1, 2021

Conditions

Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

  • Cognitive changes

    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.

    Three weeks

Study Arms (3)

Active-first

EXPERIMENTAL

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.

Device: Repetitive Transcranial Magnetic StimulationDevice: Sham Transcranial Magnetic Stimulation

Sham-first

EXPERIMENTAL

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.

Device: Repetitive Transcranial Magnetic StimulationDevice: Sham Transcranial Magnetic Stimulation

Full-course Active

ACTIVE COMPARATOR

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.

Device: Repetitive Transcranial Magnetic Stimulation

Interventions

Repetitive Transcranial Magnetic StimulationDEVICE

A non-invasive method of brain stimulation.

Active-firstFull-course ActiveSham-first
Sham Transcranial Magnetic StimulationDEVICE

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

Active-firstSham-first

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Boniface Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Mandana Modirrousta, MD PhD FRCPC

    University of Manitoba

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2015

First Posted

April 20, 2015

Study Start

September 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2021

Last Updated

October 8, 2021

Record last verified: 2021-09

Locations

CA(1)