N/A
N=14
Targeted High-definition Transcranial Direct Current Stimulation (HD-tDCS) for Reducing Post-stroke Movement Impairments
Stroke
Bottom Line
View on ClinicalTrials.gov: NCT05174949 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcome: Primary: Fugl-Meyer Upper Extremity Assessment Part A — 4.13; 5.38; 0.88 score on a scale — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Transcranial direct current stimulation (high-definition) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Oklahoma
- Primary completion
- May 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fugl-Meyer Upper Extremity Assessment Part A |
4.13; 5.38; 0.88 | <0.0001 sig |
| SECONDARY Change in Onset Latency of Transcranial Magnetic Stimulation (TMS)-Evoke Motor-evoked Potentials (MEP) |
-24.21; -22.20; 1.16 | 0.0020 sig |
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.
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
Data sourced from ClinicalTrials.gov (NCT05174949). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.