Synchronized Brain and Hand Stimulation After Stroke

NCT ID: NCT04502290

Last Updated: 2025-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2024-05-22

Brief Summary

Among the 795,000 individuals who sustain a stroke annually in the United States, 65% continue to experience moderate-to-severe impairments in one hand six months or more, which limits their ability to perform daily tasks. Currently there is dearth of understanding of the mechanisms of motor recovery after stroke. Understanding the mechanisms can potentially lead to the development of interventions to improve motor performance after stroke. The proposed study will examine how synchronously pairing brain and hand stimulation repeatedly affects the plasticity of the brain and motor performance after stroke. The knowledge gained from this study can be useful to develop interventions to improve hand movement after moderate-severe stroke.

Conditions

Stroke; Upper Extremity Paresis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Combined non-invasive brain and Functional Electrical Stimulation

In this arm of the study participants will receive repeated non-invasive brain stimulation synchronously paired with FES

Group Type: EXPERIMENTAL

Combined Non-invasive brain stimulation and functional electrical hand stimulation

Intervention Type: DEVICE

Participants will receive synchronously combined non-invasive brain stimulation (delivered via electrical/magnetic stimulation) with functional electrical stimulation (delivered via DS7A or Neuromove) of the weak hand

Interventions

Combined Non-invasive brain stimulation and functional electrical hand stimulation

Participants will receive synchronously combined non-invasive brain stimulation (delivered via electrical/magnetic stimulation) with functional electrical stimulation (delivered via DS7A or Neuromove) of the weak hand

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Male or female (either right or left handed) with unilateral hemiparesis after stroke;

2. Stroke onset of at least six months prior to the time of participation;

3. Ability to elicit motor evoked potential in the Extensor digitorum communis (EDC) muscle

4. Ability to grasp, as indicated by a score of at least 1 (out of 2) on the finger mass flexion and cylindrical grasp items of Upper Extremity Fugl-Meyer scale

5. age between 18-80 years

Exclusion Criteria

1. Presence of severe aphasia , measured by cognitive and/or language impairments that preclude the ability to follow simple instructions;

2. Excessive spasticity of wrist and finger muscles, defined as a Modified Ashworth Score more than or equal to 3, which may limit the ability to open the hand/fingers;

3. Diagnosis of neurological disorders other than stroke, which may confound the results;

4. Has touch and proprioceptive sensory deficits determined via a score of 0 on the position sense section (section H) of the Fugl Meyer Upper Extremity assessment proprioception, which may limit the ability to report excessive amount of tingling due to hand stimulation

5. History of seizure or epilepsy as the effects of TMS are not tested in individuals with seizures or epilepsy;

6. Orthopaedic/musculoskeletal conditions (eg, arthritis) affecting the upper extremity, which may limit the ability to move the affected hand

7. Presence of metallic implants in the head or neck for TMS;

8. Currently or planning to become pregnant, as the effects of TMS are not tested not pregnant women;

9. Difficulty maintaining alertness or remaining still for MRI;

10. Ferromagnetic metallic implants, pacemakers, other implanted devices, or ventilators (for MRI);

11. Bodyweight > 300 lbs due to MRI scanner dimensions

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, which may confound the results

13. Cognitive impairments, defined as a score of < 23 on the Mini Mental Status Examination, which may limit the ability to follow the commands in the study

14. Excessive pain > equal to 5 on Visual Analog Scale in the more-affected upper extremity, which may limit the ability to participate in the study

15. History of schizophrenia, Bipolar disorder (type I or II) [Answer yes to questions 16 and items of the (hypo) maniac module of the The Mini International Neuropsychiatric Interview], current moderate, severe depression (Scores of >10 on Patient Health Questionnaire-9) and other neurological or medical conditions that could confound results.

16. Life expectancy less than the duration of the study

17. Hemispatial neglect, which may limit the ability to pay attention to the affected hand

18. Participating in concurrent therapy, which may confound the results

19. We will exclude children because although stroke may occur in children, the protocol is addressing stoke in adults and the devices are not approved for use in children

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amit Sethi

OTHER

Sponsor Role: lead

Responsible Party

Amit Sethi

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Amit Sethi

Role: PRINCIPAL_INVESTIGATOR

UPitt

Locations

Neuromotor Recovery and Rehabilitation Lab

Pittsburgh, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

STUDY19070157

Identifier Type: -

Identifier Source: org_study_id