Synchronized Brain and Hand Stimulation After Stroke

Synchronized Brain and Hand Stimulation to Improve Hand Function After Stroke

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Upper Extremity Paresis
• Intervention / Treatment: Device: Combined Non-invasive brain stimulation and functional electrical hand stimulation

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amit Sethi; Phone Number: 4123836619; Email: asethi@pitt.edu

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15260
      • Recruiting
      • Neuromotor Recovery and Rehabilitation Lab
      • Contact: Amit Sethi; Phone Number: 412-383-6619; Email: asethi@pitt.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motor evoked potential	Surface EMG electrodes (Ag-AgCl) will be applied to the belly of the affected EDC muscle and a reference electrode will be placed at the clavicle. The motor evoked potential (MEP) data will be collected by stimulating the targets in the grid at 2000 Hz with Signal software (CED, Cambridge, UK).	Baseline to 6 weeks
Hand force	We will measure force production of the wrist and finger extensors (EDC) using two 34.09 kg load cells embedded in cushioned customized platforms. The height of the load cells can be altered to accommodate individual hand sizes. Participants will perform 5 trials of isometric wrist and finger extension movements against load cells for 10 seconds. The force data will be amplified by 5-20K and collected at 1000 Hz using Biopac amplifier and software (Biopac Systems Inc, Goleta, CA, USA). To allow for the deliberate increase to peak force as well as the tendency to drop off near the end of the 10-second interval, we will calculate force output over the central 5 second segment.	Baseline to 6 weeks

Collaborators and Investigators

• Sponsor: Amit Sethi
• Investigators: Principal Investigator: Amit Sethi, UPitt

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: August 3, 2020
• First Submitted That Met QC Criteria: August 5, 2020
• First Posted (Actual): August 6, 2020

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Stroke; Paresis
• Other Study ID Numbers: STUDY19070157

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No