rTMS for Post-stroke Fatigue

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05584124
• Other study ID #: N3790-W
• Secondary ID: IK2RX00379000120
• Status: Recruiting
• Phase: N/A
• Start date: April 10, 2023
• Est. completion date: October 29, 2027

Study information

• Verified date: March 2024
• Source: VA Office of Research and Development
• Contact: Brian J Cence
• Phone: (843) 792-2668
• Email: brian.cence[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 29, 2027
• Est. primary completion date: October 29, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Fatigue
• Stroke
• Stroke, Chronic

Intervention

Device:
• High frequency repetitive transcranial magnetic stimulation
MAGSTIM Super Rapid2 Plus
• Sham repetitive transcranial magnetic stimulation
MAGSTIM Super Rapid2 Plus

Locations

Country	Name	City	State
United States	Ralph H. Johnson VA Medical Center, Charleston, SC	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	Ralph H. Johnson VA Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 from baseline FSS score to 7 days after last treatment
Secondary	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 from baseline MFIS score to 7 Days after last treatment
Secondary	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 from baseline FSS score to 3 months after last treatment
Secondary	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 from baseline MFIS score to 3 months after last treatment