Magnetic Brain Stimulation in the Treatment of Mild Cognitive Impairment

Mild Cognitive Impairment Clinical Trial

Official title:

The Use of Repetitive Transcranial Magnetic Stimulation in the Treatment of Mild Cognitive Impairment Due to Brain Injury

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02420522
• Other study ID #: B2014:134
• Status: Suspended
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

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