tDCS for Post-Stroke Fatigue

Overseen By Raquel Queiruga, M.A.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Seizure, Brain injury, Depression, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 16

Duration: 2 weeks

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for individuals experiencing severe fatigue after a stroke. Researchers believe that the Soterix Mini-CT tDCS stimulator, a device used for non-invasive brain stimulation, might reduce this fatigue. The trial includes two groups: one receiving real electrical stimulation and another receiving a non-active version for comparison. It suits those who had a stroke more than three months ago, still experience severe tiredness, and can have a friend or family member present during sessions. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Do I need to stop my current medications for the trial?

No, you do not need to stop your current medications. The trial requires participants to stay on their existing medications throughout the study.

What prior data suggests that this device is safe for post-stroke fatigue?

Research has shown that transcranial direct current stimulation (tDCS), such as the Soterix Mini-CT device, is safe for humans. People generally tolerate tDCS well, with most experiencing only mild side effects, if any. Commonly reported effects include slight tingling or mild skin irritation at the electrode sites, but these are usually temporary.

The Soterix Mini-CT tDCS device has been used in various trials, providing controlled and reliable stimulation. No serious side effects are commonly linked to its use. The trial's early phase indicates that earlier studies found the treatment safe enough to continue testing. Overall, current evidence suggests that tDCS treatment is safe. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about the use of the Soterix Mini-CT tDCS stimulator for post-stroke fatigue because it offers a non-invasive and targeted approach that differs from typical pharmacological treatments. Unlike medications that often come with side effects, tDCS (transcranial Direct Current Stimulation) uses gentle electrical currents to modulate brain activity, potentially enhancing recovery with minimal risk. This novel method focuses on stimulating specific brain regions to improve energy levels and cognitive function, providing a fresh avenue of hope for stroke survivors dealing with persistent fatigue.

What evidence suggests that the Soterix Mini-CT tDCS stimulator is effective for reducing post-stroke fatigue?

Research shows that transcranial direct current stimulation (tDCS) can help reduce tiredness in people who have had a stroke. Earlier studies have found tDCS promising in easing symptoms by sending a small electrical current to the brain, targeting areas that influence fatigue. Early results suggest that applying tDCS to the left front part of the head might lessen tiredness after a stroke. In this trial, participants will be randomized to receive either real tDCS stimulation or sham tDCS stimulation using the Soterix Mini-CT tDCS device, designed to provide accurate and dependable treatment. While more research is needed, initial findings are encouraging for those experiencing fatigue after a stroke. ^{1 2 3 4 5}

Who Is on the Research Team?

Joan M Stilling, MD, MS

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

This trial is for adults over 18 who've had their first stroke more than 3 months ago and are experiencing severe fatigue. They must have a stable medication routine and someone to accompany them during treatment sessions. People with metal in the head, pacemakers, seizure history, severe brain injuries, depression/anxiety or cognitive disorders, skin issues where the device will be placed, or other major health problems can't participate.

Inclusion Criteria

Willingness to remain stable on pharmacologic therapy through the duration of the study

I experience severe fatigue.

I am over 18 years old.

Exclusion Criteria

You have a low score on a test that suggests you may have a major brain function problem.

I have no skin issues like rash or cuts where the device will be placed on my head.

Inability to provide informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive transcranial direct current stimulation (tDCS) for 20 minutes daily over the left dorsolateral prefrontal cortex for two weeks

2 weeks

14 sessions (home-based)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at the end of treatment and one month post-treatment

4 weeks

2 follow-up assessments

What Are the Treatments Tested in This Trial?

Interventions

• Soterix Mini-CT tDCS stimulator

Trial Overview The study tests if anodal tDCS (a non-invasive brain stimulation technique) applied to the left frontal area of the head can reduce post-stroke fatigue. Participants will receive either real tDCS using Soterix Mini-CT stimulator or a sham (fake) version to compare effects.

How Is the Trial Designed?

Group I: Real tDCS stimulation Experimental Treatment 1 Intervention

Subjects randomized to receive real/active electrical stimulation.

Group II: Sham tDCS stimulation Placebo Group 1 Intervention

Subjects randomized to receive sham/non-activating electrical stimulation.

Soterix Mini-CT tDCS stimulator is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Soterix Mini-CT tDCS stimulator for:

• Post-stroke fatigue
• Depression
• Anxiety
• Chronic pain

Approved in European Union as Soterix Medical 1x1-CT for:

• Post-stroke fatigue
• Major depressive disorder
• Chronic pain

Approved in Canada as 1x1 tDCS mini-CT for:

• Post-stroke fatigue
• Depression
• Anxiety

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

American Heart Association

Collaborator

Trials

352

Recruited

6,196,000+

Published Research Related to This Trial

Transcranial direct current stimulation (tDCS) was found to be feasible and safe for use in outpatient therapy for stroke patients, with 100% adherence among the 7 participants who completed the study over 5-6 weeks.

Most participants (71%) reported positive impressions of tDCS, experiencing acute improvements in function and energy, with only one adverse event unrelated to the treatment and mild side effects reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Safety of Transcranial Direct Current Stimulation in an Outpatient Rehabilitation Setting After Stroke. Cleland, BT., Galick, M., Huckstep, A., et al.[2020]

In a study involving 74 chronic stroke patients, six sessions of transcranial direct current stimulation (tDCS) combined with cognitive training did not show any additional benefits in reducing fatigue and depression symptoms compared to a sham treatment.

The analysis indicated that while fatigue and depression symptoms decreased during the intervention, the lack of added benefit from tDCS suggests that fatigue is a significant clinical concern that may affect treatment adherence and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

No add-on effect of tDCS on fatigue and depression in chronic stroke patients: A randomized sham-controlled trial combining tDCS with computerized cognitive training. Ulrichsen, KM., Kolskår, KK., Richard, G., et al.[2022]

This study will investigate the efficacy and safety of transcranial direct-current stimulation (tDCS) combined with routine rehabilitation in treating post-stroke fatigue (PSF) in 100 patients over a 4-week period.

The trial is designed as a double-blind randomized controlled study, which will help ensure reliable results regarding the effectiveness of tDCS in reducing fatigue and improving quality of life for stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of transcranial direct current stimulation on patients with post-stroke fatigue: a study protocol for a double-blind randomized controlled trial. Sun, X., Dong, X., Yuan, Q., et al.[2022]

In a study involving 19 stroke survivors, transcranial direct current stimulation (tDCS) applied to the left dorsolateral prefrontal cortex did not significantly increase the number of completed rehabilitation therapy sessions compared to sham treatment.

Despite being well tolerated, tDCS did not show an effect on participation in rehabilitation, indicating that it may not be an effective intervention for enhancing therapy session completion in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial Direct Current Stimulation to Optimise Participation in Stroke Rehabilitation - A Sham-Controlled Cross-Over Feasibility Study. Etherton-Beer, C., Lui, Y., Radalj, M., et al.[2022]

Transcranial direct current stimulation (tDCS) significantly reduced post-stroke fatigue in 60 patients after 4 weeks of treatment, showing better results compared to the control group that received sham tDCS.

tDCS also improved motor function and daily activity ability, indicating its potential as a safe and effective treatment for enhancing recovery in stroke patients, although the benefits in fatigue did not persist at the 8-week follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial to explore the efficacy and safety of transcranial direct current stimulation on patients with post-stroke fatigue. Dong, XL., Sun, X., Sun, WM., et al.[2023]

In a pilot study involving 91 subacute stroke patients, those receiving cathodal tDCS combined with conventional rehabilitation showed significant improvements in lower limb motor function compared to the control group, with notable results at both immediate post-treatment and one-month follow-up assessments.

While the results indicate that cathodal tDCS may enhance recovery of motor function, the overall effectiveness remains inconclusive, suggesting the need for larger randomized controlled trials to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Cathodal Transcranial Direct Current Stimulation for Lower Limb Subacute Stroke Rehabilitation. Duan, Q., Liu, W., Yang, J., et al.[2023]

Citations

1. soterixmedical.com soterixmedical.com/research/newsroom/clinicaltrials

Soterix Medical Clinical Trials The Soterix Medical 1X1 mini-CT device is being used in the study. The mini-CT provides unmatched control and reliability in conducting tDCS or tES trials in ...

2. soterixmedical.com soterixmedical.com/research/1x1/ct

Transcranial Electrical Stimulation (tES) for Clinical Trials The Soterix Medical 1x1 CT is a complete tDCS clinical trial hardware, software, and data management platform designed to the highest standard in pivotal single ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05816603

Transcranial Direct Current Stimulation for Post-stroke ... The investigators hypothesize that delivery of anodal tDCS to the left frontal head region will reduce fatigue severity following stroke. Detailed Description.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9521558/

Remotely monitored transcranial direct current stimulation in ... The Soterix 1x1 tDCS mini-CT will be used to deliver low-intensity tDCS in the home setting. The procedure will target the primary motor cortex ...

5. soterixmedical.com soterixmedical.com/research/remote/mini-CT

REMOTE mini-CT Two models, the 1x1 tDCS mini-CT and the 1x1 tES mini-CT, provide unmatched controlled and reliability in conducting tDCS or tES trials in deployed environments ...