tACS for Stroke Recovery

Overseen By Shengai Li, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Must not be taking: Tone alternating medications

Disqualifiers: Visual deficit, Cognitive impairment, Pacemaker, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4-8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether transcranial alternating current stimulation (tACS) can help people recover motor skills after a stroke. tACS uses a gentle electrical current on the brain to improve its function. Participants will receive either an active tACS treatment at different frequencies (10Hz or 20Hz) or a sham version that does not affect brain activity. The trial seeks stroke survivors who have lived with the condition for over six months, have some finger movement, and can give consent. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to new recovery methods for stroke survivors.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently adjusting medications that affect muscle tone, like baclofen.

What prior data suggests that this technique is safe for stroke recovery?

Research has shown that transcranial alternating current stimulation (tACS) is generally safe for people. Studies have found that both 10Hz and 20Hz tACS can be safely applied to the head. Specifically, one study found that 10Hz tACS using a current between 1.0 to 2.0 mA for 20 minutes did not cause any serious side effects. Similarly, research on 20Hz tACS indicated safety, even at higher intensities up to 4 mA, without major adverse effects. These findings suggest that tACS is a safe option for participants, with only minor side effects reported, if any. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the tACS treatments for stroke recovery because they offer a novel, non-invasive approach to enhancing brain function. Unlike standard rehabilitation therapies or medications, tACS (transcranial alternating current stimulation) directly applies a gentle electrical current to the scalp, which can potentially retrain brain waves to improve movement and cognitive recovery. The 10Hz and 20Hz frequencies are designed to specifically entrain neuronal activity at these rates, possibly leading to more effective and quicker recovery compared to existing treatments. This method holds promise for more personalized and targeted brain stimulation, which could revolutionize stroke recovery protocols.

What evidence suggests that tACS could be effective for stroke recovery?

This trial will compare different frequencies of transcranial alternating current stimulation (tACS) for stroke recovery. Research has shown that tACS can aid stroke patients in their recovery. Specifically, studies have found that a 10Hz frequency can enhance recovery by improving brain coordination, crucial for movement skills. Similarly, the 20Hz frequency has proven effective, particularly in movement-related areas, by enhancing the brain's adaptability. Both frequencies of tACS show promise in helping stroke survivors regain movement and function. These findings suggest that tACS could be a valuable tool in stroke recovery, offering hope for better outcomes. Participants in this trial may receive either the 10Hz or 20Hz tACS, or a sham version, to evaluate their effectiveness. ^{1 3 4 6 7}

Who Is on the Research Team?

Sheng Li, MD, PhD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for stroke survivors aged 18-75 who are at least 6 months post-stroke, can move their finger flexors slightly, and give consent. It's not for those with visual/hearing/cognitive impairments, recent botulinum/phenol injections, pacemakers/metal implants/oxygen therapy or women who are pregnant.

Inclusion Criteria

I can move my fingers.

It has been over 6 months since my stroke and I am medically stable.

I have had one stroke, regardless of its type or size.

Exclusion Criteria

Patients with pacemaker, metal implants or supplemental oxygen

I am currently adjusting my dose of muscle relaxants like baclofen.

I haven't had botulinum toxin injections in my arm or fingers in the last 4 months, nor phenol injections in the last 2 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive tACS intervention for motor recovery, with sessions involving 10Hz or 20Hz stimulation for 20 or 40 minutes

4-8 weeks

Multiple sessions (in-person)

Follow-up

Participants are monitored for changes in motor function and EEG activity after the tACS intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• tACS 10Hz
• tACS 20Hz
• tACS Sham

Trial Overview The study tests transcranial alternating current stimulation (tACS) to improve motor recovery after a stroke. Participants will receive either fake stimulation (sham), tACS at 10Hz frequency, or tACS at 20Hz frequency to see which helps more in recovery.

How Is the Trial Designed?

Group I: tACS Sham, tACS 10Hz, tACS 20Hz Experimental Treatment 3 Interventions

tACS Sham is a temporary non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp for up to 30 second, it is not designed to entrain neuronal activity into any external regulatory frequency patterns. tACS 10Hz is a 10Hz non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp or 20 or 40 minutes to entrain neuronal activity into 10Hz frequency patterns. tACS 20Hz is a 20Hz non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp for 20 or 40 minutes to entrain neuronal activity into 20Hz frequency patterns.

Group II: HD-tACS 20Hz, HD-tACS 10Hz, HD-tACS Sham Experimental Treatment 3 Interventions

tACS Sham is a temporary non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp for up to 30 second, it is not designed to entrain neuronal activity into any external regulatory frequency patterns. tACS 10Hz is a 10Hz non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp or 20 or 40 minutes to entrain neuronal activity into 10Hz frequency patterns. tACS 20Hz is a 20Hz non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp for 20 or 40 minutes to entrain neuronal activity into 20Hz frequency patterns.

Group III: HD-tACS 10Hz, HD-tACS 20Hz, HD-tACS Sham Experimental Treatment 3 Interventions

tACS Sham is a temporary non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp for up to 30 second, it is not designed to entrain neuronal activity into any external regulatory frequency patterns. tACS 10Hz is a 10Hz non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp or 20 or 40 minutes to entrain neuronal activity into 10Hz frequency patterns. tACS 20Hz is a 20Hz non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp for 20 or 40 minutes to entrain neuronal activity into 20Hz frequency patterns.

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Published Research Related to This Trial

Transcranial direct current stimulation (TDCS) is a noninvasive brain stimulation technique that can help in understanding brain function and may aid in the recovery of patients after a stroke.

TDCS has the potential to enhance neuroplasticity, which is crucial for stroke recovery, by modulating brain activity and facilitating rehabilitation efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation in stroke recovery. Schlaug, G., Renga, V., Nair, D.[2022]

Transcranial direct current stimulation (tDCS) did not show significant improvements in motor performance for all stroke patients immediately after treatment, but it did demonstrate effectiveness in enhancing motor function for patients with chronic stroke and mild-to-moderate impairments, based on a review of 15 studies with 315 subjects.

The results suggest that while tDCS has potential as a therapeutic tool in stroke recovery, its efficacy varies based on stroke characteristics, indicating that more research is needed to optimize its use in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation (tDCS): does it have merit in stroke rehabilitation? A systematic review. Marquez, J., van Vliet, P., McElduff, P., et al.[2022]

Transcranial direct current stimulation (tDCS) significantly improves motor recovery in stroke patients, with effect sizes of 0.26 for upper limb and 0.47 for lower limb functions based on a meta-analysis of 29 studies involving 664 subjects.

Chronic stroke patients showed notable improvements in upper limb function after tDCS, while subacute stroke patients experienced more significant benefits for lower limb function, indicating that the timing and parameters of tDCS treatment are crucial for optimizing recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Different Therapeutic Effects of Transcranial Direct Current Stimulation on Upper and Lower Limb Recovery of Stroke Patients with Motor Dysfunction: A Meta-Analysis. Bai, X., Guo, Z., He, L., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10805992/

The effect of transcranial alternating current stimulation on ... Our findings suggest that tACS improves functional recovery in patients with stroke. The application of tACS was associated with improved overall functional ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0006899325000794

Application and research progress of different frequency ... This review focuses on the current research status and possibilities of tACS with different frequencies in stroke rehabilitation.

3. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-024-07913-4

Effectiveness and brain mechanism of multi-target transcranial ... This study aims to ascertain whether multi-target tACS is more effective than single-target stimulation in stroke patients and to further explore the potential ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8002277/

The Effects of 10 Hz and 20 Hz tACS in Network Integration ... In this study, we aimed to investigate the frequency-specific stimulation effect of tACS in chronic stroke. Thirteen chronic stroke patients ...

5. frontiersin.org frontiersin.org/journals/human-neuroscience/articles/10.3389/fnhum.2021.652393/full

Improving the Effect of Transcranial Alternating Current ... Studies have shown that optimizing the number and position of electrodes during electrical stimulation has a very good effect on enhancing brain stimulation ...

6. mdpi.com mdpi.com/2076-3417/12/11/5299

Preliminary Study on Safety Assessment of 10 Hz ... In this study, the safety of tACS with selected parameters, ie, a stimulation intensity of 1.0 to 2.0 mA, a frequency of 10 Hz, and a treatment time of 20 min, ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7867505/

Transcranial alternating current stimulation (tACS): from basic ... tACS is a unique form of non-invasive brain stimulation. Sinusoidal alternating electric currents are delivered to the scalp to affect mostly cortical neurons.