rTMS for Post-stroke Fatigue

VA Office of Research and Development60 enrolled

Overview

This experimental trial is investigating the use of magnetic stimulation of the brain as a possible treatment for people with post-stroke fatigue. Fatigue is a common condition after a stroke and can negatively impact an individual's ability to perform desired social and physical activities. Magnetic stimulation of the brain has been shown to improve signs and symptoms of related psychological (e.g., depression) conditions. Participants in this trial will receive a type of magnetic stimulation called repetitive magnetic stimulation, or rTMS. The investigators will measure feelings of fatigue, and other clinical characteristics related to mood and cognition, before and after participants receive rTMS.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Stroke Stroke, Chronic Fatigue

Interventions

Eligibility

Sex: ALLMin age: 35 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 35 - 80 years of age * more than 6 months post-stroke * able to walk 10m unassisted * Clinically present fatigue Exclusion Criteria: * Contraindications to MRI/TMS/rTMS (e.g. implanted metal within the head, history of seizures) * Inability to follow simple three-step instructions * Multiple strokes on opposite hemispheres * Cerebellar and/or brainstem strokes * Diagnosed comorbid neurological conditions (e.g. multiple sclerosis, Parkinson's disease, moderate/severe TBI) * Comorbid psychological conditions (e.g. depression, anxiety, PTSD) * strokes within stimulation sites * Pregnancy * Severe hypertension (resting SBP \> 200, DBP \> 120)

Outcomes

Primary Outcomes

Change in Fatigue Severity Scale (FSS) score

The Fatigue Severity Scale (FSS) is a patient reported outcome measure assessing perceived influence of fatigue over the past week. The scale consists of nine questions measured on a 7-point Likert scale (1-7). The FSS' range of scores is from 9 (min) to 63 (max) with lower numbers representing lower/less impact of fatigue.

Time frame: Change from baseline FSS score to 7 days after last treatment

Secondary Outcomes

Change in Modified Fatigue Impact Scale (MFIS) score

The Modified Fatigue Impact Scale (MFIS) is a Patient reported outcome assessing the impact of fatigue over the past four weeks. The questionnaire is comprised of 21 questions covering three domains (physical, cognitive, and psychosocial subscales). The assessment is graded on a 5 point Likert scale (0-4). The MFIS' range of scores is from 0-84 with higher scores indicating greater impact/worse fatigue. The range of scores for the physical, cognitive, and psychosocial subscales are 0-36, 0-40, and 0-8 respectively. Greater scores indicate greater/worse impact of fatigue.

Time frame: Change from baseline MFIS score to 7 Days after last treatment