rTMS for Post-stroke Fatigue

NCT ID: NCT05584124

Last Updated: 2025-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-10

Study Completion Date

2027-10-29

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke Stroke, Chronic Fatigue

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Participants will be blinded to their groups

Study Groups

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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.

Group Type EXPERIMENTAL

High frequency repetitive transcranial magnetic stimulation

Intervention Type DEVICE

MAGSTIM Super Rapid2 Plus

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.

Group Type EXPERIMENTAL

High frequency repetitive transcranial magnetic stimulation

Intervention Type DEVICE

MAGSTIM Super Rapid2 Plus

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.

Group Type SHAM_COMPARATOR

Sham repetitive transcranial magnetic stimulation

Intervention Type DEVICE

MAGSTIM Super Rapid2 Plus

Interventions

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High frequency repetitive transcranial magnetic stimulation

MAGSTIM Super Rapid2 Plus

Intervention Type DEVICE

Sham repetitive transcranial magnetic stimulation

MAGSTIM Super Rapid2 Plus

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

35 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ralph H. Johnson VA Medical Center

FED

Sponsor Role collaborator

VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John H Kindred

Role: PRINCIPAL_INVESTIGATOR

Ralph H. Johnson VA Medical Center, Charleston, SC

Locations

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Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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IK2RX003790

Identifier Type: NIH

Identifier Source: secondary_id

View Link

00120805

Identifier Type: OTHER

Identifier Source: secondary_id

N3790-W

Identifier Type: -

Identifier Source: org_study_id

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