rTMS for Post-stroke Fatigue

March 13, 2024 updated by: VA Office of Research and Development

Neuromodulation for Rehabilitation of Post-Stroke Fatigue: An rTMS Pilot Study.

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29401-5703
        • Recruiting
        • Ralph H. Johnson VA Medical Center, Charleston, SC
        • Contact:
        • Principal Investigator:
          • John H Kindred
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Fatigue Severity Scale (FSS) score
Time Frame: 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.
Change from baseline FSS score to 7 days after last treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Modified Fatigue Impact Scale (MFIS) score
Time Frame: 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.
Change from baseline MFIS score to 7 Days after last treatment
Change in Fatigue Severity Scale (FSS) score
Time Frame: 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.
Change from baseline FSS score to 3 months after last treatment
Change in Modified Fatigue Impact Scale (MFIS) score
Time Frame: 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.
Change from baseline MFIS score to 3 months after last treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Collaborators

Ralph H. Johnson VA Medical Center

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2023

Primary Completion (Estimated)

October 29, 2027

Study Completion (Estimated)

October 29, 2027

Study Registration Dates

First Submitted

October 7, 2022

First Submitted That Met QC Criteria

October 17, 2022

First Posted (Actual)

October 18, 2022

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 13, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N3790-W
  • IK2RX003790 (U.S. NIH Grant/Contract)
  • 00120805 (Other Identifier: Ralph H. Johnson VA Medical Center)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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