Repetitive Transcranial Magnetic Stimulation, a Form of Non-invasive Brain Stimulation, as a Possible Treatment for Post-stroke Fatigue.

Part of paid clinical trials in Decatur, Georgia.

Sponsor
VA Office of Research and Development
Study ID
NCT05584124
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
34 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • High frequency repetitive transcranial magnetic stimulation — DEVICE
    MagVenture MagPro X100 with MagOption
  • Sham repetitive transcranial magnetic stimulation — DEVICE
    MagVenture MagPro X100 with MagOption

Study Details

This experimental trial is investigating the use of magnetic stimulation of the brain as a possible treatment for post-stroke fatigue in people who have had a stroke more than six months prior to enrolling. 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 transcranial 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.

Key Dates

Start date
Apr 10, 2023
Status verified
Apr 2026
Primary completion
Oct 29, 2027
Completion
Oct 29, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

Change in Fatigue Severity Scale (FSS) score [ Time Frame: Change from baseline FSS score to 7 days after last treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Atlanta VA Medical and Rehab Center, Decatur, GADecaturGeorgia30033-4004
Medina O Bello
[email protected]
404-321-6111
Kevin Mammino
[email protected]
(404) 432-6111
John H Kindred (PRINCIPAL_INVESTIGATOR)

Find similar trials in Decatur, GA

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
Atlanta VA Medical and Rehab Center, Decatur, GA· Decatur, GA

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