Clinical trial NCT02420522: Magnetic Brain Stimulation in the Treatment of Mild Cognitive Impairment
Official title: The Use of Repetitive Transcranial Magnetic Stimulation in the Treatment of Mild Cognitive Impairment Due to Brain Injury
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Mild Cognitive Impairment
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2015-04-20
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Cognitive changes
timeFrame: Three weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: St Boniface Hospital
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Mandana Modirrousta, MD PhD FRCPC
role: PRINCIPAL_INVESTIGATOR
References: