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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT02420522
Other study ID # B2014:134
Secondary ID
Status Suspended
Phase N/A
First received
Last updated
Start date September 2015
Est. completion date December 2021

Study information

Verified date September 2021
Source University of Manitoba
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Suspended
Enrollment 64
Est. completion date December 2021
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Repetitive Transcranial Magnetic Stimulation
A non-invasive method of brain stimulation.
Sham Transcranial Magnetic Stimulation
A device designed to look, sound, and feel like a real magnetic stimulation coil without actually stimulating the brain.

Locations

Country Name City State
Canada St Boniface Hospital Winnipeg Manitoba

Sponsors (1)

Lead Sponsor Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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