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

Trial Summary

What is the purpose of this trial?

The investigators hypothesize that delivery of anodal tDCS to the left frontal head region will reduce fatigue severity following stroke.

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 data supports the effectiveness of the treatment Soterix Mini-CT tDCS stimulator for post-stroke fatigue?

Research suggests that transcranial direct current stimulation (tDCS) shows potential for reducing post-stroke fatigue, improving participation in rehabilitation, and enhancing energy levels in stroke patients. Studies indicate that tDCS is feasible and safe for use in outpatient settings, with many participants reporting positive effects on their function and energy. ^{1 2 3 4 5}

How does the Soterix Mini-CT tDCS stimulator treatment differ from other treatments for post-stroke fatigue?

The Soterix Mini-CT tDCS stimulator is unique because it uses transcranial direct current stimulation (tDCS), a non-invasive method that applies a small electrical current to the brain, which may help reduce fatigue and improve attention in stroke patients. Unlike traditional drug treatments, this approach directly targets brain activity and is still being explored for its potential benefits in post-stroke fatigue. ^{2 3 4 5 6}

Research Team

Joan M Stilling, MD, MS

Principal Investigator

Weill Medical College of Cornell University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Feasibility and Safety of Transcranial Direct Current Stimulation in an Outpatient Rehabilitation Setting After Stroke. [2020]

2. United States 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. [2023]

3. England 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. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Transcranial Direct Current Stimulation to Optimise Participation in Stroke Rehabilitation - A Sham-Controlled Cross-Over Feasibility Study. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Effect of Cathodal Transcranial Direct Current Stimulation for Lower Limb Subacute Stroke Rehabilitation. [2023]

6. United States 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. [2022]