Synchronized Brain and Hand Stimulation After Stroke

NCT04502290 | Completed Results FDA Device

• 1 other identifier: STUDY19070157
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Percent Change in Box and Block Test

  The Box and Block Test (BBT) measures unilateral gross manual dexterity and the ability to release objects. It is a quick, simple and inexpensive test. It can be used with a wide range of populations, including clients with stroke. The BBT is composed of a wooden box divided in two compartments by a partition and 150 blocks. The BBT administration consists of asking the participants to move, one by one, the maximum number of blocks from one compartment of a box to another of equal size, within 60 seconds. The box is oriented lengthwise and placed at the client's midline, with the compartment holding the blocks oriented towards the hand being tested. Participants first perform this test with their unaffected hand in order to practice and register baseline scores. Additionally, a 15-second trial period is permitted at the beginning of each side. Before the trial, after the standardized instructions are given to participants are advised that their fingertips must cross the partition when

  Baseline to 6 weeks

Secondary Outcomes (2)

• Percent Change in Motor Evoked Potential

  Baseline to 6 weeks

• Average Percent Change in Hand Force

  Baseline to 6 weeks

Study Arms (1)

Combined non-invasive brain and Functional Electrical Stimulation

EXPERIMENTAL

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

Device: Combined Non-invasive brain stimulation and functional electrical hand stimulation

Interventions

Combined Non-invasive brain stimulation and functional electrical hand stimulation 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

Combined non-invasive brain and Functional Electrical Stimulation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female (either right or left handed) with unilateral hemiparesis after stroke;
• Stroke onset of at least six months prior to the time of participation;
• Ability to elicit motor evoked potential in the Extensor digitorum communis (EDC) muscle
• 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
• age between 18-80 years

You may not qualify if:

• Presence of severe aphasia , measured by cognitive and/or language impairments that preclude the ability to follow simple instructions;
• 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;
• Diagnosis of neurological disorders other than stroke, which may confound the results;
• 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
• History of seizure or epilepsy as the effects of TMS are not tested in individuals with seizures or epilepsy;
• Orthopaedic/musculoskeletal conditions (eg, arthritis) affecting the upper extremity, which may limit the ability to move the affected hand
• Presence of metallic implants in the head or neck for TMS;
• Currently or planning to become pregnant, as the effects of TMS are not tested not pregnant women;
• Difficulty maintaining alertness or remaining still for MRI;
• Ferromagnetic metallic implants, pacemakers, other implanted devices, or ventilators (for MRI);
• Bodyweight \> 300 lbs due to MRI scanner dimensions
• 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
• 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
• 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
• 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.

Sponsors & Collaborators

• Amit Sethi: lead

Study Sites (1)

Neuromotor Recovery and Rehabilitation Lab

Pittsburgh, Pennsylvania, 15260, United States

Location

MeSH Terms

Conditions

Stroke; Paresis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Amit Sethi
• Organization: University of Pittsburgh

asethi@pitt.edu

4123836619

Study Officials

• Amit Sethi

  UPitt

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 3, 2020
• First Posted: August 6, 2020
• Study Start: October 1, 2020
• Primary Completion: May 22, 2024
• Study Completion: May 22, 2024
• Last Updated: July 15, 2025
• Results First Posted: July 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)