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

University of Oklahoma (OU)

Status: Completed

Conditions: Stroke

Treatments: Device: Transcranial direct current stimulation (high-definition)

Study type: Interventional

Funder types: Other

Identifiers

NCT05174949

14011

Details and patient eligibility

About

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.

Full 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.

Enrollment: 14 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

14 participants in 6 patient groups

Sham, Anodal, Cathodal

Experimental group

Description:

Treatment order 1: Sham, Anodal, Cathodal

Treatment:

Device: Transcranial direct current stimulation (high-definition)

Anodal, Cathodal, Sham

Experimental group

Description:

Treatment order 2: Anodal, Cathodal, Sham

Treatment:

Device: Transcranial direct current stimulation (high-definition)

Cathodal, Sham, Anodal

Experimental group

Description:

Treatment order 3: Cathodal, Sham, Anodal

Treatment:

Device: Transcranial direct current stimulation (high-definition)

Sham, Cathodal, Anodal

Experimental group

Description:

Treatment order 4: Sham, Cathodal, Anodal

Treatment:

Device: Transcranial direct current stimulation (high-definition)

Cathodal, Anodal, Sham

Experimental group

Description:

Treatment order 5: Cathodal, Anodal, Sham

Treatment:

Device: Transcranial direct current stimulation (high-definition)

Anodal, Sham, Cathodal

Experimental group

Description:

Treatment order 6: Anodal, Sham, Cathodal

Treatment:

Device: Transcranial direct current stimulation (high-definition)