Combining brain, nerve, and hand stimulation to improve hand movement after stroke

Strengthening Task Specific Activation of Paretic Hand Muscles After moderate-to- Severe Chronic Stroke

This study is testing if combining brain, nerve, and hand stimulation can help people who have had a moderate-to-severe stroke improve their hand movement and function.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: University of Utah (Academic / other)
• Locations: 1 site (Salt Lake City, Utah)
• Trial ID: NCT05736653 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of combined brain, nerve, and hand stimulation on hand movement in individuals who have experienced a moderate-to-severe stroke. Researchers will enroll 40 participants who will undergo three intervention sessions designed to enhance the connection between the brain and weak hand muscles. The study will assess both short-term and long-term effects of the stimulation techniques on hand function and movement. Participants will engage in specific tasks involving grasping and releasing a ball, with varying stimulation protocols applied during these tasks.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-85 who have experienced a first-ever subcortical stroke at least six months prior and have some ability to grasp objects.

Not a fit: Patients with severe aphasia, excessive spasticity, or other neurological disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve hand movement and function in stroke survivors, enhancing their quality of life.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in enhancing motor function through combined stimulation techniques.

Eligibility criteria

Inclusion Criteria:

1. Age between 18-85 years
2. Diagnosis of first-ever subcortical stroke (single cerebrovascular accident)
3. Stroke onset of at least six months prior to the time of participation
4. A score of at least 1 out of 2 on the spherical grasping item of the Fugl-Meyer Upper Extremity Subscale to allow participants to grasp the ball
5. Cognitive skills to actively participate, as indicated by scores of \> 23 on the Mini-Mental Status Examination
6. English speaking

Exclusion Criteria:

1. Inability to elicit a motor evoked potential (MEP) in the EDC muscle even with a 20% background muscle contraction
2. Presence of severe aphasia
3. Excessive spasticity of the wrist and finger muscles, defined as a Modified Ashworth Score \>2
4. Diagnosis of neurological disorders other than stroke
5. History of seizure or epilepsy
6. Orthopedic/musculoskeletal conditions (e.g., arthritis) affecting the upper extremity
7. Presence of metallic implants in the head or neck
8. Currently or planning to become pregnant
9. Difficulty maintaining alertness or remaining still
10. Ferromagnetic metallic implants, pacemakers, other implanted devices, or ventilators for magnetic resonance imaging (MRI)
11. Bodyweight \> 300 lbs due to MRI scanner dimensions (for subjects also undergoing MRI)
12. Psychiatric diagnosis according to the criteria of the Diagnostic and Statistical Manual of Mental Disorder, Fifth Edition (DSM-V), or who are on psychotropic medication
13. Life expectancy less than the duration of the study
14. Excessive pain in the paretic hand, defined as a Visual Analog Scale Score \>4
15. Participation in concurrent occupational therapy
16. Current use of recreational drugs and stimulants like cocaine and methylenedioxymethamphetamine (MDMA)

Where this trial is running

Salt Lake City, Utah

• Neural Plasticity Rehabilitation and Movement Dynamics Lab — Salt Lake City, Utah, United States (Recruiting)

Study contacts

• Principal investigator: Amit Sethi, PhD — University of Utah
• Study coordinator: Amit Sethi, PhD

Conditions Stroke; Hand; Brain stimulation