Electrical Stimulation for Post-Stroke Fatigue

Overseen By Hui-Ting Goh

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Texas Woman's University

Must not be taking: Fatigue medications

Disqualifiers: Acute medical problems, Depression, others

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

Compensation: Varies

Number of Visits: 7

Duration: 1 week

32 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether transcranial direct current stimulation (tDCS), a type of electrical brain stimulation, can reduce fatigue in stroke survivors. Participants will receive either real or sham (fake) stimulation for five consecutive days. Researchers will assess the impact on fatigue levels immediately after treatment and again one month later. Individuals who experienced a stroke over three months ago and suffer from significant fatigue may qualify for this trial. As an unphased trial, it offers participants the chance to contribute to innovative research that could lead to new treatments for stroke-related fatigue.

Will I have to stop taking my current medications?

Yes, you may need to stop taking medications that affect your level of fatigue, as they are listed in the exclusion criteria for the trial.

What prior data suggests that this electrical stimulation technique is safe for post-stroke fatigue?

Research has shown that anodal transcranial direct current stimulation (tDCS) is generally safe for stroke survivors. One study found that many patients felt less tired after receiving real tDCS compared to those who received a placebo treatment, suggesting the treatment might be effective without causing major issues.

A safety review of tDCS found that side effects are rare and usually mild, such as a slight tingling sensation on the scalp. No serious problems have been reported in these studies, which is reassuring.

Overall, these findings suggest that anodal tDCS is well-tolerated. However, individual experiences may vary. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for post-stroke fatigue involve medication or rehabilitation therapies, but transcranial direct current stimulation (tDCS) offers something different by using electrical currents to potentially boost brain activity. The anodal tDCS targets the ipsilesional primary motor cortex, aiming to enhance neural recovery and reduce fatigue more directly than traditional methods. Researchers are excited because this approach is non-invasive and may offer a novel mechanism to improve energy and function in stroke survivors, potentially leading to quicker and more effective relief from fatigue.

What evidence suggests that this trial's treatments could be effective for post-stroke fatigue?

This trial will compare the effects of anodal transcranial direct current stimulation (tDCS) with sham tDCS in reducing tiredness after a stroke. Research suggests that anodal tDCS, a type of gentle electrical stimulation, might alleviate tiredness by boosting brain activity in stroke-affected areas. One study found that a single session of this treatment on the brain's movement control area improved tiredness for up to a week. However, results vary across studies, and it might not work for everyone. More research is needed to confirm these findings and identify who benefits the most. ^{1 4 5 6 7}

Who Is on the Research Team?

Hui-Ting Goh

Principal Investigator

Physical Therapy

Are You a Good Fit for This Trial?

This trial is for adults who've had a stroke at least 3 months ago, can follow simple instructions, and experience significant fatigue (scoring ≥4 on the Fatigue Severity Scale). They should be able to move their affected arm somewhat. People with acute health issues, contraindications to the study's procedures, severe depression, pain that affects arm movement or medications influencing fatigue levels cannot participate.

Inclusion Criteria

I had a stroke more than 3 months ago.

I can move my arm enough to reach out for things.

You have a high average score on the Fatigue Severity Scale (FSS).

Exclusion Criteria

Acute medical problems

I have significant depression, scoring over 10 on a depression scale.

You have any reasons why you should not have tDCS, MRI, or TMS.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either real or sham transcranial direct current stimulation (tDCS) for 5 consecutive days

1 week

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at baseline, immediately after intervention, and 1 month after

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Anodal transcranial direct current stimulation
• Sham transcranial direct current stimulation

Trial Overview The study tests if anodal transcranial direct current stimulation (tDCS) over part of the brain affected by stroke can reduce post-stroke fatigue. Participants will get either real or sham tDCS daily for five days. The effects on behavior and brain function are assessed before, right after treatment and one month later.

How Is the Trial Designed?

Group I: Anodal tDCS group Experimental Treatment 1 Intervention

Participants will receive anodal tDCS applied to the ipsilesional primary motor cortex.

Group II: Sham tDCS Placebo Group 1 Intervention

Participants will receive sham tDCS applied to the ipsilesional primary motor cortex

Anodal transcranial direct current stimulation is already approved in United States, European Union, Canada, China for the following indications:

Approved in United States as Transcranial Direct Current Stimulation for:

• Post-stroke fatigue
• Depression
• Chronic pain

Approved in European Union as Transcranial Direct Current Stimulation for:

• Post-stroke fatigue
• Depression
• Chronic pain
• Multiple sclerosis-related fatigue

Approved in Canada as Transcranial Direct Current Stimulation for:

• Post-stroke fatigue
• Depression
• Chronic pain

Approved in China as Transcranial Direct Current Stimulation for:

• Post-stroke fatigue
• Depression
• Chronic pain

Who Is Running the Clinical Trial?

Texas Woman's University

Lead Sponsor

Trials

90

Recruited

5,900+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

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

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

Transcranial direct current stimulation (tDCS) has been shown to be a promising treatment for depression and fatigue in Multiple Sclerosis, with a meta-analysis of 18 high-quality randomized controlled trials indicating it is moderately to highly recommendable due to its effectiveness and negligible side effects.

The study utilized the GRADE criteria and PICO model to evaluate tDCS treatments, highlighting its low-cost and easy-to-use nature, which supports its potential inclusion in medical therapies for conditions related to brain electrical activity imbalances.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

tDCS randomized controlled trials in no-structural diseases: a quantitative review. Gianni, E., Bertoli, M., Simonelli, I., et al.[2021]

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 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 study involving multiple sclerosis patients with fatigue, five days of anodal transcranial direct current stimulation (tDCS) did not significantly change overall fatigue scores for the group, indicating limited efficacy in the general population.

However, a subgroup analysis revealed that patients with higher lesion loads in the left frontal cortex responded better to tDCS, suggesting that this treatment may be beneficial for specific patients with identifiable brain changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of transcranial direct current stimulation on fatigue in multiple sclerosis. Saiote, C., Goldschmidt, T., Timäus, C., et al.[2015]

Transcranial Direct Current Stimulation (tDCS) is generally considered safe, but there are concerns that it could lead to significant negative effects in healthy individuals.

The scientific community needs to be alerted about the potential risks of tDCS, emphasizing the importance of protecting healthy volunteers from possible harm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of transcranial direct current stimulation in healthy participants. Boccard-Binet, S., Sen, A.[2021]

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]

Transcranial direct current stimulation (tDCS) has shown positive effects in reducing fatigue symptoms in patients with multiple sclerosis (MS), particularly cognitive fatigue, based on a systematic review of 8 studies.

Most studies reported no serious side effects from tDCS, suggesting it is a safe intervention; however, the variability in treatment protocols and short follow-up periods indicate the need for larger, more standardized studies to confirm its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of tDCS on the fatigue in patients with multiple sclerosis: A systematic review of randomized controlled clinical trials. Ashrafi, A., Mohseni-Bandpei, MA., Seydi, M.[2020]

Transcranial Direct Current Stimulation (tDCS) has been shown to be safe, with no reports of Serious Adverse Effects or irreversible injuries across over 33,200 sessions involving more than 1,000 subjects, including vulnerable populations.

Safety assessments indicate that the current densities used in conventional tDCS (≤4 milliamperes) are significantly lower than those that could potentially cause brain injury, suggesting that tDCS protocols are well within safe limits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. Bikson, M., Grossman, P., Thomas, C., et al.[2022]

Transcranial direct current stimulation (tDCS) is generally considered safe, with mild and transient adverse effects reported in clinical trials, but the frequency and relationship of these effects with clinical variables remain unclear due to selective reporting bias.

Out of 209 studies reviewed, 117 mentioned adverse effects, with common issues like itching and tingling reported more frequently in the active tDCS group, although these differences were not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. Brunoni, AR., Amadera, J., Berbel, B., et al.[2022]

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 10 patients with multiple sclerosis, anodal transcranial direct current stimulation (tDCS) significantly reduced fatigue by an average of 26%, demonstrating its potential efficacy as a non-pharmacological treatment.

The results suggest that targeting the primary somatosensory areas with personalized tDCS can effectively alleviate fatigue symptoms in mildly disabled MS patients, improving their quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multiple sclerosis fatigue relief by bilateral somatosensory cortex neuromodulation. Tecchio, F., Cancelli, A., Cottone, C., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8289762/

Effect of transcranial direct current stimulation on post-stroke ... Our results show that a single session of bilateral anodal tDCS over the primary motor cortex improves fatigue symptoms for up to a week after stimulation.

2. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-022-06128-9

Effects of transcranial direct current stimulation on patients ... This study will provide insight into the efficacy of transcranial direct-current stimulation for post-stroke fatigue. This is a double-blind ...

3. journals.lww.com journals.lww.com/md-journal/fulltext/2021/10150/a_randomized_controlled_trial_to_explore_the.32.aspx

A randomized controlled trial to explore the efficacy and... Post-stroke fatigue seriously affects the quality of life for stroke patients. There is no effective treatment at present. transcranial direct ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2215016124000839

A randomized-controlled crossover trial protocol This study will be able to determine the optimal cortical stimulation site to effectively reduce fatigue among late subacute and chronic stroke survivors living ...

5. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06088914?draw=2&rank=1

Behavioral and Neural Correlates of Post-Stroke Fatigue Recent clinical trials using anodal transcranial direct current stimulation (tDCS) to modulate brain excitability reported mixed clinical efficacy in ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05816603

Transcranial Direct Current Stimulation for Post-stroke ... The purpose of this study is to investigate transcranial direct current stimulation (tDCS) as a home-based non-pharmacologic intervention for post-stroke ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5389927/

Safety Review of transcranial Direct Current Stimulation in ... This review analyzes the reported adverse effects in stroke, looking for factors that may induce side-effects.