Bilateral Stimulation for Stroke

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Oklahoma Health Sciences Center, Oklahoma City, OK
Stroke
Transcranial direct current stimulation (high- definition) - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

Significant motor impairments occur in 80% of individuals after moderate to severe stroke and impact the body side to the lesioned hemisphere. Typical motor impairments involve loss of dexterity with highly prevalent upper limb flexion synergy. Advances in treating flexion synergy impairments have been hampered by a lack of precision rehabilitation. Previous studies suggest and support the role of cortico-reticulospinal tract (CRST) hyperexcitability in post-stroke flexion synergy. CRST hyperexcitability is often caused by damage to the corticospinal tract (CST). We hypothesize that: 1) inhibiting the contralesional dorsal premotor cortex (cPMd) will directly reduce the CRST hyperexcitability and thus, reduce the expression of the flexion synergy; 2) facilitating the ipsilesional primary motor cortex (iM1) will improve the excitability of the damaged CST, therefore reducing the CRST hyperexcitability and the flexion synergy. we propose to use a novel targeted high-definition tDCS (THD-tDCS) to specifically modulate the targeted cortical regions for testing his hypothesis, via the following aims: Aim 1. Evaluate the effect of cathodal THD-tDCS over the cPMd on reducing the CRST hyperexcitability and the expression of flexion synergy. Aim 2. Evaluate the effect of anodal THD-tDCS over the iM1 on improving the excitability of the CST, and determine whether this, thus, also reduces the CRST hyperexcitability and the flexion synergy. Aim 3. Evaluate the confluence effect of bilateral THD-tDCS, i.e., simultaneous cathodal stimulation over the cPMd and anodal over the iM1.

Treatment Effectiveness

Study Objectives

2 Primary · 2 Secondary · Reporting Duration: Baseline (initial visit), before (within 30 minutes range) and immediately after (within 30 minutes range) the intervention

Baseline (initial visit), before (within 30 min range) and immediately after (within 30 min range) the intervention
Change in Transcranial Magnetic Stimulation-Evoke Motor-evoked Potential 1: Ispilesional stimulation in the brain and contralateral response in the muscle
Baseline (initial visit), before (within 30 minutes range) and immediately after (within 30 minutes range) the intervention
Change in Fugl-Meyer Upper Extremity assessment
Change in Transcranial Magnetic Stimulation-Evoke Motor-evoked Potential 2: Contralesional stimulation in the brain and ipsilateral response in the muscle
Change in a subset of Fugl-Meyer Upper Extremity assessment which is mainly related to the muscle synergies
Modified Ashworth Scale

Trial Safety

Trial Design

4 Treatment Groups

Bilateral Stimulation
1 of 4
Anodal stimulation
1 of 4
Cathodal stimulation
1 of 4
Sham stimulation
1 of 4
Active Control
Non-Treatment Group

30 Total Participants · 4 Treatment Groups

Primary Treatment: Bilateral Stimulation · Has Placebo Group · N/A

Bilateral Stimulation
Device
ActiveComparator Group · 1 Intervention: Transcranial direct current stimulation (high- definition) · Intervention Types: Device
Anodal stimulation
Device
ActiveComparator Group · 1 Intervention: Transcranial direct current stimulation (high- definition) · Intervention Types: Device
Sham stimulation
Device
ShamComparator Group · 1 Intervention: Transcranial direct current stimulation (high- definition) · Intervention Types: Device
Cathodal stimulation
Device
ActiveComparator Group · 1 Intervention: Transcranial direct current stimulation (high- definition) · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline (initial visit), before (within 30 minutes range) and immediately after (within 30 minutes range) the intervention
Closest Location: University of Oklahoma Health Sciences Center · Oklahoma City, OK
Photo of ok university of oklahoma health sciences center 1Photo of ok university of oklahoma health sciences center 2Photo of oklahoma city 3
2002First Recorded Clinical Trial
2 TrialsResearching Stroke
411 CompletedClinical Trials

Who is running the clinical trial?

American Heart AssociationOTHER
280 Previous Clinical Trials
5,824,156 Total Patients Enrolled
35 Trials studying Stroke
3,923,379 Patients Enrolled for Stroke
University of OklahomaLead Sponsor
410 Previous Clinical Trials
95,576 Total Patients Enrolled
3 Trials studying Stroke
66 Patients Enrolled for Stroke

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have paresis confined to one side, with substantial motor impairment of the paretic upper limb.
You have the capacity to give informed consent.\n

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.