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

NCT ID: NCT05174949

Last Updated: 2024-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-18
• Study Completion Date: 2023-05-12

Brief 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.

Detailed 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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Sham, Anodal, Cathodal

Treatment order 1: Sham, Anodal, Cathodal

Group Type: EXPERIMENTAL

Transcranial direct current stimulation (high-definition)

Intervention Type: DEVICE

Three conditions (2 mA, 20 mins):

1. anodal stimulation over the ipsilesional primary motor cortex

2. cathodal one over the contralesional premotor cortex

3. Sham

Anodal, Cathodal, Sham

Treatment order 2: Anodal, Cathodal, Sham

Group Type: EXPERIMENTAL

Transcranial direct current stimulation (high-definition)

Intervention Type: DEVICE

Three conditions (2 mA, 20 mins):

1. anodal stimulation over the ipsilesional primary motor cortex

2. cathodal one over the contralesional premotor cortex

3. Sham

Cathodal, Sham, Anodal

Treatment order 3: Cathodal, Sham, Anodal

Group Type: EXPERIMENTAL

Transcranial direct current stimulation (high-definition)

Intervention Type: DEVICE

Three conditions (2 mA, 20 mins):

1. anodal stimulation over the ipsilesional primary motor cortex

2. cathodal one over the contralesional premotor cortex

3. Sham

Sham, Cathodal, Anodal

Treatment order 4: Sham, Cathodal, Anodal

Group Type: EXPERIMENTAL

Transcranial direct current stimulation (high-definition)

Intervention Type: DEVICE

Three conditions (2 mA, 20 mins):

1. anodal stimulation over the ipsilesional primary motor cortex

2. cathodal one over the contralesional premotor cortex

3. Sham

Cathodal, Anodal, Sham

Treatment order 5: Cathodal, Anodal, Sham

Group Type: EXPERIMENTAL

Transcranial direct current stimulation (high-definition)

Intervention Type: DEVICE

Three conditions (2 mA, 20 mins):

1. anodal stimulation over the ipsilesional primary motor cortex

2. cathodal one over the contralesional premotor cortex

3. Sham

Anodal, Sham, Cathodal

Treatment order 6: Anodal, Sham, Cathodal

Group Type: EXPERIMENTAL

Transcranial direct current stimulation (high-definition)

Intervention Type: DEVICE

Three conditions (2 mA, 20 mins):

1. anodal stimulation over the ipsilesional primary motor cortex

2. cathodal one over the contralesional premotor cortex

3. Sham

Interventions

Transcranial direct current stimulation (high-definition)

Three conditions (2 mA, 20 mins):

1. anodal stimulation over the ipsilesional primary motor cortex

2. cathodal one over the contralesional premotor cortex

3. Sham

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oklahoma Shared Clinical and Translational Resources

OTHER

Sponsor Role: collaborator

University of Oklahoma

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Countries

United States

References

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 Stimulation (NIBS) 2022.

Reference Type: RESULT

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 (CSM), San Diego, CA, Feb 23-25, 2023

Reference Type: RESULT

Williamson JN, James SA, He D, Li S, Sidorov EV, Yang Y. High-definition transcranial direct current stimulation for upper extremity rehabilitation in moderate-to-severe ischemic stroke: a pilot study. Front Hum Neurosci. 2023 Oct 12;17:1286238. doi: 10.3389/fnhum.2023.1286238. eCollection 2023.

Reference Type: DERIVED

PMID: 37900725 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

14011

Identifier Type: -

Identifier Source: org_study_id