Back to resultsrTMS for Post-stroke Fatigue
Primary Purpose
Stroke, Stroke, Chronic, Fatigue
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High frequency repetitive transcranial magnetic stimulation
Sham repetitive transcranial magnetic stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring non-invasive brain stimulation, post-stroke fatigue, perception of fatigue, repetitive transcranial magnetic stimulation, rTMS
Eligibility Criteria
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)
Sites / Locations
- Ralph H. Johnson VA Medical Center, Charleston, SCRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Sham Comparator
Arm Label
Real M1 High Frequency rTMS
Real LDLPFC High Frequency rTMS
Sham rTMS
Arm Description
Participants will be randomly assigned to receive high-frequency repetitive transcranial magnetic stimulation (rTMS) to the top of their head for approximately 40 minutes.
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT05584124
First Posted
October 7, 2022
Last Updated
May 2, 2023
Sponsor
VA Office of Research and Development
Collaborators
Ralph H. Johnson VA Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT05584124
Brief Title
rTMS for Post-stroke Fatigue
Official Title
Neuromodulation for Rehabilitation of Post-Stroke Fatigue: An rTMS Pilot Study.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 10, 2023 (Actual)
Primary Completion Date
October 29, 2027 (Anticipated)
Study Completion Date
October 29, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
Ralph H. Johnson VA Medical Center
4. Oversight
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
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Stroke, Chronic, Fatigue
Keywords
non-invasive brain stimulation, post-stroke fatigue, perception of fatigue, repetitive transcranial magnetic stimulation, rTMS
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Participants will be blinded to their groups
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Real M1 High Frequency rTMS
Arm Type
Experimental
Arm Description
Participants will be randomly assigned to receive high-frequency repetitive transcranial magnetic stimulation (rTMS) to the top of their head for approximately 40 minutes.
Arm Title
Real LDLPFC High Frequency rTMS
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham rTMS
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
High frequency repetitive transcranial magnetic stimulation
Intervention Description
MAGSTIM Super Rapid2 Plus
Intervention Type
Device
Intervention Name(s)
Sham repetitive transcranial magnetic stimulation
Intervention Description
MAGSTIM Super Rapid2 Plus
Primary Outcome Measure Information:
Title
Change in Fatigue Severity Scale (FSS) score
Description
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 Outcome Measure Information:
Title
Change in Modified Fatigue Impact Scale (MFIS) score
Description
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
Title
Change in Fatigue Severity Scale (FSS) score
Description
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 3 months after last treatment
Title
Change in Modified Fatigue Impact Scale (MFIS) score
Description
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 3 months after last treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brian J Cence
Phone
(843) 792-2668
Email
brian.cence@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Alyssa Chesnutt
Phone
(843) 792-8171
Email
hydar@musc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John H Kindred
Organizational Affiliation
Ralph H. Johnson VA Medical Center, Charleston, SC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ralph H. Johnson VA Medical Center, Charleston, SC
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401-5703
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian J Cence
Phone
843-792-2668
Email
brian.cence@va.gov
First Name & Middle Initial & Last Name & Degree
Alyssa Chesnutt
Phone
(843) 792-8171
Email
hydar@musc.edu
First Name & Middle Initial & Last Name & Degree
John H Kindred
12. IPD Sharing Statement
Plan to Share IPD
No
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rTMS for Post-stroke Fatigue
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