rTMS for Post-stroke Fatigue

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05584124
• Collaborator: Ralph H. Johnson VA Medical Center (U.S. Fed)
• Enrollment: 60
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 53.9
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke; Stroke, Chronic; Fatigue	Device: High frequency repetitive transcranial magnetic stimulation; Device: Sham repetitive transcranial magnetic stimulation	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Masking Description: Participants will be blinded to their groups
• Primary Purpose: Treatment
• Official Title: Neuromodulation for Rehabilitation of Post-Stroke Fatigue: An rTMS Pilot Study.
• Anticipated Study Start Date: May 1, 2023
• Anticipated Primary Completion Date: Oct 29, 2027
• Anticipated Study Completion Date: Oct 29, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Real M1 High Frequency rTMS Participants will be randomly assigned to receive high-frequency repetitive transcranial magnetic stimulation (rTMS) to the top of their head for approximately 40 minutes.	Device: High frequency repetitive transcranial magnetic stimulation; MAGSTIM Super Rapid2 Plus
Experimental: Real LDLPFC High Frequency rTMS Participants will be randomly assigned to receive high-frequency repetitive transcranial magnetic stimulation (rTMS) to the left frontal part of their head for approximately 40 minutes.	Device: High frequency repetitive transcranial magnetic stimulation; MAGSTIM Super Rapid2 Plus
Sham Comparator: Sham rTMS Participants will be randomly assigned to receive sham/placebo repetitive transcranial magnetic stimulation (rTMS) to the their head for approximately 40 minutes. This is a control condition.	Device: Sham repetitive transcranial magnetic stimulation; MAGSTIM Super Rapid2 Plus

Outcome Measures

Primary Outcome Measures

1. Change in Fatigue Severity Scale (FSS) score [Change from baseline FSS score to 7 days after last treatment]

   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.

Secondary Outcome Measures

1. Change in Modified Fatigue Impact Scale (MFIS) score [Change from baseline MFIS score to 7 Days after last treatment]

   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.

2. Change in Fatigue Severity Scale (FSS) score [Change from baseline FSS score to 3 months after last treatment]

   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.

3. Change in Modified Fatigue Impact Scale (MFIS) score [Change from baseline MFIS score to 3 months after last treatment]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ralph H. Johnson VA Medical Center, Charleston, SC	Charleston	South Carolina	United States	29401-5703

Sponsors and Collaborators

• VA Office of Research and Development
• Ralph H. Johnson VA Medical Center

Investigators

• Principal Investigator: John H Kindred, Ralph H. Johnson VA Medical Center, Charleston, SC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT05584124
• Other Study ID Numbers: N3790-W; IK2RX003790; 00120805
• First Posted: Oct 18, 2022
• Last Update Posted: Jan 17, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by VA Office of Research and Development: non-invasive brain stimulation; post-stroke fatigue; perception of fatigue; repetitive transcranial magnetic stimulation; rTMS
• Additional relevant MeSH terms: Stroke; Fatigue

Study Results

No Results Posted as of Jan 17, 2023