What side effects are associated with this type of intervention?

Transcranial direct current stimulation (tDCS) is generally well-tolerated, with common side effects including mild tingling, itching, or redness at the site of electrode placement. Other non-invasive neuromodulation techniques, such as transcranial magnetic stimulation (TMS), may cause headaches, scalp discomfort, or, rarely, seizures. Invasive treatments like deep brain stimulation (DBS) carry risks of infection, hemorrhage, and hardware malfunctions. Standard pharmacological treatments for stroke, such as anticoagulants and antiplatelet agents, can lead to bleeding complications. Rehabilitation therapies, while essential, may sometimes result in muscle soreness or fatigue.

What prior FDA approvals exist?

Transcranial direct current stimulation (tDCS) is being studied for its potential benefits in post-stroke fatigue and its anti-inflammatory effects. While tDCS itself is not yet FDA-approved specifically for stroke treatment, other neuromodulation techniques like transcranial magnetic stimulation (TMS) have received FDA approval for various neurological conditions, including migraine. These techniques aim to modulate neural activity, similar to the goals of tDCS. Currently, there are no specific FDA-approved drugs or treatments for stroke that focus on the same mechanisms as tDCS, but ongoing research continues to explore these possibilities.

What other types of research exist?

Promising alternatives to tDCS for stroke patients include Transcranial Magnetic Stimulation (TMS) and Noninvasive Vagus Nerve Stimulation (nVNS). TMS has demonstrated efficacy in modulating neural activity and providing sustained pain relief. nVNS has shown potential benefits in acute treatment and may have anti-inflammatory effects. Both are approved for use and have been supported by clinical trials.

← Back to Search

Behavioural Intervention

tDCS for Post-Stroke Fatigue

N/A

Waitlist Available

Led By John H Kindred, Ph.D.

Research Sponsored by Medical University of South Carolina

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged 35-80 years

Able to walk 10m unassisted

Must not have

Absolute contraindications to MRI, TMS (transcranial magnetic stimulation), or tDCS (e.g., implanted metal devices, history of seizure, and surgical clips or staples)

Multiple strokes on opposite hemispheres

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, post-intervention (2-weeks)

Awards & highlights

Summary

This trial will investigate whether transcranial direct current stimulation (tDCS) can help improve fatigue and inflammation after a stroke.

Who is the study for?

This trial is for individuals aged 35-80 who can walk on their own and have experienced fatigue for at least 6 months following a stroke. It's not suitable for those with multiple strokes in different brain hemispheres, other neurological conditions like MS or Parkinson's, severe high blood pressure, certain types of strokes, metal implants that interfere with MRI/TMS/tDCS, or ongoing depression/anxiety disorders.Check my eligibility

What is being tested?

The study is testing the effects of anodal transcranial direct current stimulation (a-tDCS), which delivers small electrical currents to the brain to see if it can reduce post-stroke fatigue and inflammation compared to sham (fake) stimulation.See study design

What are the potential side effects?

tDCS may cause mild side effects such as itching, tingling, or discomfort at the electrode site. More serious risks include headache, nausea, or dizziness but these are rare. The sham treatment has no active components so any side effects would be minimal.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 35 and 80 years old.

Select...

I can walk 10 meters by myself.

Select...

I have been feeling tired for the last 6 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I don't have metal implants, a seizure history, or surgical clips that prevent MRI or TMS.

Select...

I have had strokes in both sides of my brain.

Select...

I have very high blood pressure.

Select...

I have had a stroke or lesion in my cerebellum or brainstem.

Select...

I have a diagnosed neurological condition like MS, Parkinson's, or dementia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, post-intervention (2-weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, post-intervention (2-weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, post-intervention (2-weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Fatigue Severity Scale (FSS) score

Secondary outcome measures

Change in Fatigue Assessment Scale (FAS)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: RealExperimental Treatment1 Intervention

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 II: ShamPlacebo Group1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

anodal transcranial direct current stimulation (a-tDCS)

2022

N/A

~20

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for stroke include thrombolytic therapy, which dissolves blood clots to restore blood flow, and mechanical thrombectomy, which physically removes clots. Neuromodulation techniques like transcranial direct current stimulation (tDCS) modulate neural activity by applying a low electrical current to the brain, potentially enhancing neuroplasticity and reducing inflammation. Understanding these mechanisms is crucial for stroke patients as it helps tailor treatments to improve recovery outcomes, reduce complications, and enhance overall brain function post-stroke.