Post-stroke Fatigue, Inflammation, tDCS

NCT ID: NCT05330988

Last Updated: 2024-12-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-12

Study Completion Date

2024-03-01

Brief Summary

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Fatigue is a common condition after an individual has a stroke. While the negative impacts of post-stroke fatigue are well known, the knowledge of the causes of post-stroke fatigue and effective treatments for post-stroke fatigue are lacking. This small study will investigate the possible benefits of transcranial direct current stimulation (tDCS), which uses small electrical currents supplied by a 9-volt battery, on post-stroke fatigue and investigate tDCS' possible anti-inflammatory effects.

Detailed Description

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Conditions

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Stroke Fatigue Chronic Stroke Stroke Sequelae

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Real

Randomly selected participants will receive 20 min. of anodal transcranial direct current stimulation to the the top of their heads. The current will slowly be ramped up over 30 secs.

Group Type EXPERIMENTAL

anodal transcranial direct current stimulation (a-tDCS)

Intervention Type DEVICE

The 1x1 platform is the most state-of-the-art, customizable, and reliable platform for pad-based Transcranial Electrical Stimulation.

Sham

Randomly selected participants will receive 20 min. of sham transcranial direct current stimulation to the top of their heads. Sham stimulation is accomplished by turning on the device and slowly increasing and subsequently decreasing the amount of current to zero. This occurs over 30 secs.

Group Type SHAM_COMPARATOR

sham stimulation

Intervention Type DEVICE

The 1x1 platform is the most state-of-the-art, customizable, and reliable platform for pad-based Transcranial Electrical Stimulation.

Interventions

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anodal transcranial direct current stimulation (a-tDCS)

The 1x1 platform is the most state-of-the-art, customizable, and reliable platform for pad-based Transcranial Electrical Stimulation.

Intervention Type DEVICE

sham stimulation

The 1x1 platform is the most state-of-the-art, customizable, and reliable platform for pad-based Transcranial Electrical Stimulation.

Intervention Type DEVICE

Other Intervention Names

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1x1 - tDCS, Soterix Medical, US Patents: US9956395B2, US8818515B2, US8718778B2. 1x1 - tDCS, Soterix Medical, US Patents: US9956395B2, US8818515B2, US8718778B2.

Eligibility Criteria

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Inclusion Criteria

* Men and women of any race or ethnicity
* 35-80 years of age
* 6+ months post-stroke
* Have clinically present fatigue for 6 months
* Able to walk 10m unassisted

Exclusion Criteria

* Absolute contraindications to MRI, TMS (transcranial magnetic stimulation), or tDCS (e.g., implanted metal devices, history of seizure, and surgical clips or staples)
* Inability to understand and provide written informed consent
* Multiple strokes on opposite hemispheres
* Diagnosed comorbid neurological conditions (e.g. multiple sclerosis, Parkinson's disease, and dementia)
* Severe hypertension
* Cerebellar or brainstem strokes/lesions
* Concurrent depression and/or anxiety disorders
Minimum Eligible Age

35 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

National Center of Neuromodulation for Rehabilitation

OTHER

Sponsor Role collaborator

Medical University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

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John H Kindred

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John H Kindred, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

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Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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P2CHD086844

Identifier Type: NIH

Identifier Source: secondary_id

View Link

00118687

Identifier Type: -

Identifier Source: org_study_id