Targeted High-definition Transcranial Direct Current Stimulation (HD-tDCS) for Reducing Post-stroke Movement Impairments

Stroke Clinical Trial

Official title:

Targeted HD-tDCS for Reducing Post-stroke Movement Impairments

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05174949
• Other study ID #: 14011
• Status: Recruiting
• Phase: N/A
• Start date: January 18, 2022
• Est. completion date: June 2023

Study information

• Verified date: October 2022
• Source: University of Oklahoma
• Contact: Yuan Yang, PhD
• Phone: 918-660-3290
• Email: yuan.yang-2[@]ou.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Stroke is the leading cause of serious, long-term disability. The emergence of abnormal muscle synergies following a stroke presents a major limitation to the recovery of independent function. Despite the development of many interventions for movement recovery post-stroke, rehabilitation treatments are minimally effective to the muscle synergy impairment. Previous studies have found that muscle synergy impairment is associated with the damage to the corticospinal tract and the maladaptive recruitment of the contralesional cortico-reticulospinal tract. The investigators hypothesize that facilitating the damaged cortico-spinal tract (via primary motor cortex) and/or inhibiting the contralesional cortico-reticulospinal tract (via dorsal premotor cortex) will reduce muscle synergy impairment. In this pilot project, the investigators propose to run a proof-of-concept pilot trial to evaluate the effect of the targeted high-definition transcranial direct current stimulation (HD-tDCS) on mitigating muscle synergy impairment.

Description:

This randomized, double-blinded, sham-controlled cross-over study will include three stimulation conditions: 1) anodal stimulation over the ipsilesional primary motor cortex, 2) cathodal one over the contralesional premotor cortex, 3) sham stimulation in chronic hemiparetic stroke patients.

Stroke participants (> 3 months after stroke) with moderate to severe motor impairments (Fugl-Meyer Motor Assessment - Upper Extremity score between 10-40, in absence of clinically defined sensory deficits) and an ischemic unilateral subcortical lesion will receive each type of stimulation for 20 minutes.

Their brain activity and behavior data will be collected for the outcome measures.

The patient time commitment in this study is approximately 7 weeks where subjects have 3 x 1-day intervention and measurements, with 2 weeks washout period in between.

The total number of potential enrolled subjects in this pilot study is 12.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Ischemic unilateral stroke lesion (confirmed by the most recent clinical or radiological reports) at least 3 months prior to participation in this project.

• Paresis confined to one side, with moderate to severe motor impairment of the upper limb (Fugl-Meyer upper extremity scores of 10-40)

• Capacity to provide informed consent

Exclusion Criteria:

• Muscle tone abnormalities and motor or sensory impairment in the unimpaired limb

• Severe wasting or contracture or significant sensory deficits in the paretic upper limb

• Severe cognitive or affective dysfunction that prevents normal communication and understanding of consent or instruction

• Severe concurrent medical problems (e.g. cardiorespiratory impairment)

• Using a pacemaker

• Metal implants in the head

• Known adverse reaction to TMS and tDCS

• Pregnant

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Transcranial direct current stimulation (high-definition)
Three conditions: anodal stimulation over the ipsilesional primary motor cortex cathodal one over the contralesional premotor cortex Sham

Locations

Country	Name	City	State
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
University of Oklahoma	Oklahoma Shared Clinical and Translational Resources

Country where clinical trial is conducted

United States, 

References & Publications (2)

Lepak L.V., Cheema C.F, James S.A., Yang Y (2023), Computer-Guided Non-Invasive High-Definition Transcranial Direct Current Brain Stimulation as a Targeted Intervention after a Stroke, American Physical Therapy Association (APTA) Combined Sections Meeting

Williamson J, James SA, Apple B, Sharps J, Sidorov E.V., Yang Y, (2022), High Definition Transcranial Direct Current Stimulation for Improving Upper Extremity Motor Function post Stroke. June 8-10, the 3rd International Workshop on Non-Invasive Brain Stim

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Brain symmetry index	This is a neurophysiological measure that determines the acute effort of HD-tDCS on brain plasticity.	Baseline (initial visit), before (within 30 min range) and immediately after (within 30 mins range) the intervention
Primary	Change in a subset of Fugl-Meyer Upper Extremity assessment which is mainly related to the muscle synergies	This measure determines the expression of the muscle synergy impairment after a stroke	Baseline (initial visit), before (within 30 min range) and immediately after (within 30 min range) the intervention
Secondary	Change in Transcranial magnetic stimulation (TMS)-evoke motor-evoked potentials (MEP)	This is a neurophysiological measure that determines the use of ipsilesional corticospinal tract and the contralesional cortico-reticulospinal tract.	Baseline (initial visit), before (within 30 min range) and immediately after (within 30 mins range) the intervention