StrokeNCT05330988

Post-stroke Fatigue, Inflammation, tDCS

A study testing anodal transcranial direct current stimulation (a-tDCS) in people with Stroke and Fatigue, run by Medical University of South Carolina at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 35 to 80 years
Conditions the study is for: Stroke, Fatigue, Chronic Stroke
What is being tested?: anodal transcranial direct current stimulation (a-tDCS)
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 12 participants
Where: 1 siteUnited States
Study dates: 12 Jul 2022to 1 Mar 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 35 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Medical University of South Carolina
Charleston, South Carolina, 29425

Other trials in United States

About this study

Official title: Effects of tDCS on Post-stroke Fatigue and Inflammation

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.

Conditions: Stroke, Fatigue, Chronic Stroke, Stroke Sequelae
Being tested: anodal transcranial direct current stimulation (a-tDCS), sham stimulation
Medical subject headings: Stroke, Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

anodal transcranial direct current stimulation (a-tDCS)Device
Also called 1x1 - tDCS, Soterix Medical, US Patents: US9956395B2, US8818515B2, US8718778B2.
The 1x1 platform is the most state-of-the-art, customizable, and reliable platform for pad-based Transcranial Electrical Stimulation.
sham stimulationDevice
Also called 1x1 - tDCS, Soterix Medical, US Patents: US9956395B2, US8818515B2, US8718778B2.
The 1x1 platform is the most state-of-the-art, customizable, and reliable platform for pad-based Transcranial Electrical Stimulation.

Study groups in NCT05330988
Study group	Role	What they receive
Real	Experimental	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. Receives: Device: anodal transcranial direct current stimulation (a-tDCS)
Sham	Sham comparator	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. Receives: Device: sham stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Fatigue Severity Scale (FSS) Score
Patient reported outcome measuring trait fatigue over the past 7 days. Minimum score = 7 maximum score = 63, higher scores indicate greater fatigue
Measured: Baseline, post-intervention (2-weeks)

Secondary outcomes (1)

Change in Fatigue Assessment Scale (FAS)
Patient reported outcome measuring trait fatigue. Minimum score = 10 maximum score = 50, higher scores indicate greater fatigue
Measured: Baseline, post-intervention (2-weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Jul 20221 Mar 2024

First posted15 Apr 2022
Study start12 Jul 2022
Primary completion31 Oct 2023
Study completion1 Mar 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for StrokeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05330988
Sponsor's protocol ID: 00118687
Other IDs: P2CHD086844
Status last verified: Nov 2024
First submitted: 8 Apr 2022
Last updated: 10 Dec 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Yes: All of the individual participant data that underlie the results reported in the article, after de-identification.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Xeomin® and Gait Related Mobility After Stroke
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EEG Feedback-Based Vagus Nerve Stimulation for Post-Stroke Dysphagia
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All Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of tDCS on Post-stroke Fatigue and Inflammation
ClinicalTrials.gov ID: NCT05330988
Acronym / sponsor ID: 00118687
Conditions: Stroke, Fatigue, Chronic Stroke, Stroke Sequelae
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Medical University of South CarolinaUniversity, hospital or other
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Center of Neuromodulation for Rehabilitation
Study start: 12 Jul 2022 (actual)
Primary completion: 31 Oct 2023 (actual)
Study completion: 1 Mar 2024 (actual)
First posted: 15 Apr 2022 (actual)
Results: Posted 10 Dec 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Real	Experimental	Device: anodal transcranial direct current stimulation (a-tDCS)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.
Sham	Sham comparator	Device: sham stimulationRandomly 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.

Who may qualify

Ages: 35 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
anodal transcranial direct current stimulation (a-tDCS)Also: 1x1 - tDCS, Soterix Medical, US Patents: US9956395B2, US8818515B2, US8718778B2.The 1x1 platform is the most state-of-the-art, customizable, and reliable platform for pad-based Transcranial Electrical Stimulation.	Device	Real
sham stimulationAlso: 1x1 - tDCS, Soterix Medical, US Patents: US9956395B2, US8818515B2, US8718778B2.The 1x1 platform is the most state-of-the-art, customizable, and reliable platform for pad-based Transcranial Electrical Stimulation.	Device	Sham

Primary outcome

Change in Fatigue Severity Scale (FSS) Score
Time frame: Baseline, post-intervention (2-weeks)
Patient reported outcome measuring trait fatigue over the past 7 days. Minimum score = 7 maximum score = 63, higher scores indicate greater fatigue

1 secondary outcome

Change in Fatigue Assessment Scale (FAS)
Time frame: Baseline, post-intervention (2-weeks)

Results and safety

Results posted to the registry on 10 Dec 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Real	6	6
Sham	6	6

Primary outcome: Change in Fatigue Severity Scale (FSS) Score

Time frame: Baseline, post-intervention (2-weeks). Mean (Standard Deviation). Unit: units on a scale

Measure	Real n = 6	Sham n = 6
Value	-0.4 (0.9)	0.2 (0.4)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: AEs were recorded before and immediately after each treatment session (5 days) by research staff administering the treatment. During follow-up, AEs were recorded during phone calls at 7, 14, and 28 days after an individual's last treatment session.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Real	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Sham	0 of 6 (0%)	0 of 6 (0%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. All of the individual participant data that underlie the results reported in the article, after de-identification.

Related trials for Stroke

Recruiting
Delay AvoIding Primary Evaluation for ThRombectomy of Acute StrokE Patients With Large Vessel OCclusion in the Angiography SuiTe
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RecruitingPhase 4
Xeomin® and Gait Related Mobility After Stroke
Stroke
RecruitingObservational study
Implementing Transcranial Direct Current Stimulation in a Rehabilitation Setting
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Not yet recruiting
EEG Feedback-Based Vagus Nerve Stimulation for Post-Stroke Dysphagia
Ischemic Stroke, Post-stroke Dysphagia
RecruitingObservational study
Development and Validation of Risk Prediction Models for Stroke and Cognitive Impairment in Moyamoya Disease and Moyamoya Syndrome
Moyamoya Disease, Moyamoya Syndrome

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

John H Kindred, Ph.D. principal investigator

Medical University of South Carolina

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing anodal transcranial direct current stimulation (a-tDCS) in people with Stroke and Fatigue, run by Medical University of South Carolina at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Fatigue Severity Scale (FSS) Score (time frame: Baseline, post-intervention (2-weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05330988.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024.