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

14 Participants Needed

Trial Summary

What is the purpose of this trial?

The overall goal is to investigate the effectiveness of a novel intervention - transcranial alternating current stimulation (tACS) for motor recovery in 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 data supports the effectiveness of the treatment tACS for stroke recovery?

Research on a similar treatment, transcranial direct current stimulation (tDCS), shows it can help improve motor function in stroke patients, especially those with chronic or mild-to-moderate impairments. This suggests that tACS, which is another form of brain stimulation, might also be beneficial for stroke recovery. ^{1 2 3 4 5}

How does tACS differ from other stroke recovery treatments?

Transcranial alternating current stimulation (tACS) is unique because it uses non-invasive electrical currents to modulate brain activity, potentially enhancing recovery by improving neurological function and brain blood flow in stroke patients. Unlike traditional therapies, tACS specifically targets brain oscillations at different frequencies to influence motor control and brain network integration, offering a novel approach to stroke rehabilitation. ^{6 7 8 9 10}

Research Team

Sheng Li, MD, PhD

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

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

Effect of anodal versus cathodal transcranial direct current stimulation on stroke rehabilitation: a pilot randomized controlled trial. [2016]

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

Transcranial direct current stimulation in stroke recovery. [2022]

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

Transcranial direct current stimulation (tDCS): does it have merit in stroke rehabilitation? A systematic review. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation: a noninvasive tool to facilitate stroke recovery. [2022]

5. United States 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. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Efficacy of transcranial alternating current stimulation over bilateral mastoids (tACSbm) on enhancing recovery of subacute post-stroke patients. [2019]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Neurophysiological aftereffects of 10 Hz and 20 Hz transcranial alternating current stimulation over bilateral sensorimotor cortex. [2021]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of 10 Hz and 20 Hz transcranial alternating current stimulation (tACS) on motor functions and motor cortical excitability. [2015]

9. Switzerland pubmed.ncbi.nlm.nih.gov

The Effects of 10 Hz and 20 Hz tACS in Network Integration and Segregation in Chronic Stroke: A Graph Theoretical fMRI Study. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Boosting brain excitability by transcranial high frequency stimulation in the ripple range. [2021]