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tDCS + CCFES-mediated Functional Task Practice for Post-stroke Upper Extremity Hemiplegia

Primary Purpose

Stroke, Upper Extremity Paresis, Hemiplegia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active conventional tDCS montage plus CCFES
Active unconventional tDCS montage plus CCFES
Sham tDCS plus CCFES
CCFES with Occupational Therapy
Sponsored by
MetroHealth Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Rehabilitation, Therapy, Electrical Stimulation, Brain stimulation, Hand, CCFES, Motor Cortex, TMS, Motor Recovery, Central Nervous System, CVA, Upper Limb

Eligibility Criteria

21 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age ≥ 21 and ≤ 90 ≥ 6 months since first clinical hemorrhagic or nonhemorrhagic stroke Able to follow 3-stage command Able to remember 2 of 3 items after 30 minutes Full volitional elbow extension/flexion and hand opening/closing of unaffected limb Adequate active movement of shoulder and elbow to position the paretic hand in the workspace for table-top task practice Patient must be able to sit unassisted in an armless straight-back chair for the duration of the screening portion of the eligibility assessment Medically stable ≥ 10° finger and wrist extension Skin intact on hemiparetic arm, hand and scalp Muscle contraction can be elicited with Transcranial Magnetic Stimulation Unilateral upper limb hemiparesis with finger extensor strength of ≤ grade 4/5 on the Medical Research Council (MRC) scale Score of ≥1/14 and ≤ 11/14 on the hand section of the upper extremity Fugl-Meyer Assessment While relaxed, surface NMES of finger extensors and thumb extensors and/or abductors produces a functional degree of hand opening without pain. Exclusion Criteria: Co-existing neurological condition other than prior stroke involving the hemiparetic upper limb (e.g., peripheral nerve injury, PD, SCI, TBI, MS). Uncontrolled seizure disorder Use of seizure lowering threshold medications and the discretion of the study physician Cardiac pacemaker or other implanted electronic device Pregnant IM Botox injections in any UE muscle in the last 3 months Insensate arm, forearm, or hand Deficits in communication that interfere with reasonable study participation Severely impaired cognition and communication Uncompensated hemi-neglect (extinguishing to double simultaneous stimulation) Severe shoulder or hand pain (unable to position hand in the workspace without pain)

Sites / Locations

  • MetroHealth Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Sham Comparator

Arm Label

Active conventional tDCS plus CCFES

Active unconventional tDCS plus CCFES

Sham tDCS plus CCFES

Arm Description

The conventional tDCS montages involves placing the surface anode electrode on the scalp of the lesioned hemisphere and the surface cathode electrode on the scalp of the non-lesioned hemisphere. TDCS will deliver a low current while participants are undergoing CCFES-mediated functional task practice.

The unconventional tDCS montages involves placing the surface anode electrode on the scalp of the non-lesioned hemisphere and the surface cathode electrode on the scalp of the lesioned hemisphere. TDCS will deliver a low current while participants are undergoing CCFES-mediated functional task practice.

The sham tDCS montages involves placing the surface electrodes on the scalp over the lesioned and the non-lesioned hemisphere. TDCS will not be delivered during CCFES-mediated functional task practice.

Outcomes

Primary Outcome Measures

Box and Blocks Test (BBT)
The BBT counts how many blocks a patient can pick up, move over a barrier, and release in 60 seconds.

Secondary Outcome Measures

Upper Extremity Fugl-Meyer Assessment (UEFM).
The UEFM is a reliable and valid measure of post-stroke upper limb motor impairment

Full Information

First Posted
April 14, 2023
Last Updated
August 18, 2023
Sponsor
MetroHealth Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05866003
Brief Title
tDCS + CCFES-mediated Functional Task Practice for Post-stroke Upper Extremity Hemiplegia
Official Title
tDCS During Contralaterally Controlled FES for Upper Extremity Hemiplegia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2023 (Actual)
Primary Completion Date
April 2028 (Anticipated)
Study Completion Date
April 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
MetroHealth Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
After a stroke, it is very common to lose the ability to open the affected hand. Occupational and physical rehabilitation therapy (OT and PT) combined with non-invasive brain stimulation may help a person recover hand movement. The purpose of this study is to compare 3 non-invasive brain stimulation protocols combined with therapy to see if they result in different amounts of recovery of hand movement after a stroke.
Detailed Description
This study is a randomized clinical trail (RCT) of stroke survivors with chronic (6 to 24 months) hemiplegia randomized to: 1) conventional transcranial direct current stimulation (tDCS), 2) unconventional tDCS, or 3) sham tDCS during contralaterally controlled functional electrical stimulation mediated occupational therapy. The treatment will last 12 weeks and be followed by a 6-month follow-up period. Assessors, therapists and participants will be blinded to which tDCS treatment is received. This will be the first RCT of tDCS + CCFES.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Upper Extremity Paresis, Hemiplegia
Keywords
Stroke, Rehabilitation, Therapy, Electrical Stimulation, Brain stimulation, Hand, CCFES, Motor Cortex, TMS, Motor Recovery, Central Nervous System, CVA, Upper Limb

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
63 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active conventional tDCS plus CCFES
Arm Type
Active Comparator
Arm Description
The conventional tDCS montages involves placing the surface anode electrode on the scalp of the lesioned hemisphere and the surface cathode electrode on the scalp of the non-lesioned hemisphere. TDCS will deliver a low current while participants are undergoing CCFES-mediated functional task practice.
Arm Title
Active unconventional tDCS plus CCFES
Arm Type
Active Comparator
Arm Description
The unconventional tDCS montages involves placing the surface anode electrode on the scalp of the non-lesioned hemisphere and the surface cathode electrode on the scalp of the lesioned hemisphere. TDCS will deliver a low current while participants are undergoing CCFES-mediated functional task practice.
Arm Title
Sham tDCS plus CCFES
Arm Type
Sham Comparator
Arm Description
The sham tDCS montages involves placing the surface electrodes on the scalp over the lesioned and the non-lesioned hemisphere. TDCS will not be delivered during CCFES-mediated functional task practice.
Intervention Type
Device
Intervention Name(s)
Active conventional tDCS montage plus CCFES
Intervention Description
tDCS is a non-invasive brain stimulation technique. A small machine (9-volt battery operated device) will use a weak amount of electric current to stimulate the brain without any invasive procedure. Electrodes, covered in sponges soaked in saline, will be placed over certain parts of your head and held in place using a rubber strap. In addition, an electrical stimulator will be used to deliver electrical current through surface electrodes to produce hand opening by making the paretic finger and thumb extensor muscles contract.
Intervention Type
Device
Intervention Name(s)
Active unconventional tDCS montage plus CCFES
Intervention Description
tDCS is a non-invasive brain stimulation technique. A small machine (9-volt battery operated device) will use a weak amount of electric current to stimulate the brain without any invasive procedure. Electrodes, covered in sponges soaked in saline, will be placed over certain parts of your head and held in place using a rubber strap. In addition, An electrical stimulator will be used to deliver electrical current through surface electrodes to produce hand opening by making the paretic finger and thumb extensor muscles contract.
Intervention Type
Device
Intervention Name(s)
Sham tDCS plus CCFES
Intervention Description
An electrical stimulator will be used to deliver electrical current through surface electrodes to produce hand opening by making the paretic finger and thumb extensor muscles contract. The stimulator can be programmed to deliver stimulation with an intensity that corresponds to the opening of a glove instrumented with sensors and plugged into the stimulator.
Intervention Type
Behavioral
Intervention Name(s)
CCFES with Occupational Therapy
Intervention Description
An electrical stimulator will be used to deliver electrical current through surface electrodes to produce hand opening by making the paretic finger and thumb extensor muscles contract. The stimulator can be programmed to deliver stimulation with an intensity that corresponds to the opening of a glove instrumented with sensors and plugged into the stimulator. During the lab visits, all participants will use CCFES to assist hand opening during occupational therapy task practice.
Primary Outcome Measure Information:
Title
Box and Blocks Test (BBT)
Description
The BBT counts how many blocks a patient can pick up, move over a barrier, and release in 60 seconds.
Time Frame
Change in BBT will be assessed at 6 weeks, 12 weeks, 24 weeks, and 36 weeks
Secondary Outcome Measure Information:
Title
Upper Extremity Fugl-Meyer Assessment (UEFM).
Description
The UEFM is a reliable and valid measure of post-stroke upper limb motor impairment
Time Frame
Change in UEFM will be assessed at 6 weeks, 12 weeks, 24 weeks, and 36 weeks
Other Pre-specified Outcome Measures:
Title
Neurophysiologic Assessments
Description
Neurophysiologic assessments will be performed using TMS. Measures of excitability and inhibition will be measured.
Time Frame
Change in neurophysiologic assessments will be assessed at 6 weeks, 12 weeks, 24 weeks, and 36 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 21 and ≤ 90 ≥ 6 months since first clinical hemorrhagic or nonhemorrhagic stroke Able to follow 3-stage command Able to remember 2 of 3 items after 30 minutes Full volitional elbow extension/flexion and hand opening/closing of unaffected limb Adequate active movement of shoulder and elbow to position the paretic hand in the workspace for table-top task practice Patient must be able to sit unassisted in an armless straight-back chair for the duration of the screening portion of the eligibility assessment Medically stable ≥ 10° finger and wrist extension Skin intact on hemiparetic arm, hand and scalp Muscle contraction can be elicited with Transcranial Magnetic Stimulation Unilateral upper limb hemiparesis with finger extensor strength of ≤ grade 4/5 on the Medical Research Council (MRC) scale Score of ≥1/14 and ≤ 11/14 on the hand section of the upper extremity Fugl-Meyer Assessment While relaxed, surface NMES of finger extensors and thumb extensors and/or abductors produces a functional degree of hand opening without pain. Exclusion Criteria: Co-existing neurological condition other than prior stroke involving the hemiparetic upper limb (e.g., peripheral nerve injury, PD, SCI, TBI, MS). Uncontrolled seizure disorder Use of seizure lowering threshold medications and the discretion of the study physician Cardiac pacemaker or other implanted electronic device Pregnant IM Botox injections in any UE muscle in the last 3 months Insensate arm, forearm, or hand Deficits in communication that interfere with reasonable study participation Severely impaired cognition and communication Uncompensated hemi-neglect (extinguishing to double simultaneous stimulation) Severe shoulder or hand pain (unable to position hand in the workspace without pain)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amy Friedl, MS,OTR/L
Phone
2169573581
Email
afriedl@metrohealth.org
First Name & Middle Initial & Last Name or Official Title & Degree
David Cunningham, PhD
Phone
216957-3349
Email
dxc536@case.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David A Cunningham, PhD
Organizational Affiliation
MetroHealth Medical Center and Case Western Reserve University
Official's Role
Principal Investigator
Facility Information:
Facility Name
MetroHealth Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Friedl, MS, OTR/L
Phone
216-957-3581
Email
afriedl@metrohealth.org
First Name & Middle Initial & Last Name & Degree
David A Cunningham, PhD
Phone
216-957-3349
Email
dxc536@case.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

tDCS + CCFES-mediated Functional Task Practice for Post-stroke Upper Extremity Hemiplegia

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