search
Back to results

Synchronized Brain and Hand Stimulation After Stroke

Primary Purpose

Stroke, Upper Extremity Paresis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Combined Non-invasive brain stimulation and functional electrical hand stimulation
Sponsored by
Amit Sethi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Neuromotor Recovery and Rehabilitation LabRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Combined non-invasive brain and Functional Electrical Stimulation

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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).
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.

Full Information

First Posted
August 3, 2020
Last Updated
September 7, 2023
Sponsor
Amit Sethi
search

1. Study Identification

Unique Protocol Identification Number
NCT04502290
Brief Title
Synchronized Brain and Hand Stimulation After Stroke
Official Title
Synchronized Brain and Hand Stimulation to Improve Hand Function After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Amit Sethi

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Upper Extremity Paresis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Combined non-invasive brain and Functional Electrical Stimulation
Arm Type
Experimental
Arm Description
In this arm of the study participants will receive repeated non-invasive brain stimulation synchronously paired with FES
Intervention Type
Device
Intervention Name(s)
Combined Non-invasive brain stimulation and functional electrical hand stimulation
Intervention Description
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
Primary Outcome Measure Information:
Title
Box and block test
Description
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
Time Frame
Baseline to 6 weeks
Secondary Outcome Measure Information:
Title
Motor evoked potential
Description
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).
Time Frame
Baseline to 6 weeks
Title
Hand force
Description
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.
Time Frame
Baseline to 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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); 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. Life expectancy less than the duration of the study Hemispatial neglect, which may limit the ability to pay attention to the affected hand Participating in concurrent therapy, which may confound the results 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amit Sethi
Phone
4123836619
Email
asethi@pitt.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amit Sethi
Organizational Affiliation
UPitt
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neuromotor Recovery and Rehabilitation Lab
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15260
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amit Sethi
Phone
412-383-6619
Email
asethi@pitt.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Synchronized Brain and Hand Stimulation After Stroke

We'll reach out to this number within 24 hrs