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Clinical Trials/NCT04502290
NCT04502290
Completed
Not Applicable

Synchronized Brain and Hand Stimulation to Improve Hand Function After Stroke

Amit Sethi1 site in 1 country10 target enrollmentOctober 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Amit Sethi
Enrollment
10
Locations
1
Primary Endpoint
Percent Change in Box and Block Test
Status
Completed
Last Updated
9 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2020
End Date
May 22, 2024
Last Updated
9 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Amit Sethi
Responsible Party
Sponsor Investigator
Principal Investigator

Amit Sethi

Assistant Professor

University of Pittsburgh

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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);

Outcomes

Primary Outcomes

Percent Change in Box and Block Test

Time Frame: Baseline to 6 weeks

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

Secondary Outcomes

  • Percent Change in Motor Evoked Potential(Baseline to 6 weeks)
  • Average Percent Change in Hand Force(Baseline to 6 weeks)

Study Sites (1)

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