Back to resultsImproving Stroke Motor Control With Non-invasive Brain Stimulation and Functional Electrical Stimulation
Primary Purpose
Stroke, Rehabilitation, Hand
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
transcranial direct current stimulation and electrical stimulator
Sponsored by
About this trial
This is an interventional treatment trial for Stroke
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 21
- ≥ 6 months since first clinical hemorrhagic or nonhemorrhagic stroke
- Able to follow 3-stage commands and 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 extension
Unilateral upper limb hemiparesis with finger extensor strength of ≤ grade 4/5 on the manual muscle test AND a score of
≥1 and ≤ 11/14 on the hand section of the upper extremity Fugl-Meyer Assessment
- Skin intact on hemiparetic arm, hand and scalp
- While relaxed, surface neuromuscular electrical stimulation of finger extensors and thumb extensors and/or abductors produces a functional degree of hand opening without pain.
- No significant visual or hearing impairment
Exclusion Criteria:
- Co-existing neurological condition other than prior stroke involving the hemiparetic upper limb (e.g., peripheral nerve injury, Parkinson's disease, spinal cord injury, traumatic brain injury, multiple sclerosis).
- Uncontrolled seizure disorder
- Use of seizure lowering threshold medications at the discretion of the study physician (Dr. Rich Wilson)
- Cardiac pacemaker or other implanted electronic device and/or stent
- Pregnant
- Intramuscular botox injections in any upper extremity muscle in the last 3 months
- Insensate arm, forearm, or hand
- 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)
- Metal implant in the head
Sites / Locations
- MetroHealth Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Sham Comparator
Arm Label
conventional tDCS concurrent with CCFES
unconventional tDCS concurrent with CCFES
conventional tDCS preceding CCFES
unconventional tDCS preceding CCFES
sham tDCS with CCFES
Arm Description
tDCS anode placed over the lesioned hemisphere and cathode placed over the non-lesioned hemisphere
tDCS cathode placed over the lesioned hemisphere and anode placed over the non-lesioned hemisphere
tDCS anode placed over the lesioned hemisphere and cathode placed over the non-lesioned hemisphere
tDCS cathode placed over the lesioned hemisphere and anode placed over the non-lesioned hemisphere
sham tDCS preceding and concurrent with CCFES
Outcomes
Primary Outcome Measures
Corticospinal Excitability
Change in corticospinal excitability will be measured with transcranial magnetic stimulation
Reaction Time
Change in reaction time will be assessed with visual and auditory cues.
Secondary Outcome Measures
Full Information
NCT ID
NCT03857529
First Posted
February 26, 2019
Last Updated
October 28, 2022
Sponsor
MetroHealth Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03857529
Brief Title
Improving Stroke Motor Control With Non-invasive Brain Stimulation and Functional Electrical Stimulation
Official Title
Contralaterally Controlled FES Plus Transcranial Direct Current Stimulation for Hand Motor Control After Stroke: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
August 1, 2024 (Anticipated)
Study Completion Date
August 1, 2024 (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
Data Monitoring Committee
No
5. Study Description
Brief Summary
This pilot study for stroke patients with chronic upper limb hemiplegia will examine the effects of non-invasive brain stimulation and neuromuscular electrical stimulation on hand motor control and corticospinal excitability. Specifically, this study will investigate the effects of timing and delivery of tDCS in conjunction with contralaterally controlled functional electrical stimulation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Rehabilitation, Hand
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
conventional tDCS concurrent with CCFES
Arm Type
Experimental
Arm Description
tDCS anode placed over the lesioned hemisphere and cathode placed over the non-lesioned hemisphere
Arm Title
unconventional tDCS concurrent with CCFES
Arm Type
Experimental
Arm Description
tDCS cathode placed over the lesioned hemisphere and anode placed over the non-lesioned hemisphere
Arm Title
conventional tDCS preceding CCFES
Arm Type
Experimental
Arm Description
tDCS anode placed over the lesioned hemisphere and cathode placed over the non-lesioned hemisphere
Arm Title
unconventional tDCS preceding CCFES
Arm Type
Experimental
Arm Description
tDCS cathode placed over the lesioned hemisphere and anode placed over the non-lesioned hemisphere
Arm Title
sham tDCS with CCFES
Arm Type
Sham Comparator
Arm Description
sham tDCS preceding and concurrent with CCFES
Intervention Type
Device
Intervention Name(s)
transcranial direct current stimulation and electrical stimulator
Intervention Description
Contralaterally Controlled Functional Electrical Stimulation: 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 will be programmed to deliver stimulation with an intensity that corresponds to the opening of a glove instrumented with sensors and plugged into the stimulator (i.e., CCFES).
Transcranial direct current stimulation (tDCS): TDCS is a method of noninvasive stimulation of the brain. Using electrodes placed in saline-soaked sponges, low level of direct current (1mA) is delivered over the scalp. This intervention is considered safe and noninvasive because it does not involve implantation or injection or any skin penetration.
Primary Outcome Measure Information:
Title
Corticospinal Excitability
Description
Change in corticospinal excitability will be measured with transcranial magnetic stimulation
Time Frame
up to one hour post intervention
Title
Reaction Time
Description
Change in reaction time will be assessed with visual and auditory cues.
Time Frame
up to one hour post intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 21
≥ 6 months since first clinical hemorrhagic or nonhemorrhagic stroke
Able to follow 3-stage commands and 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 extension
Unilateral upper limb hemiparesis with finger extensor strength of ≤ grade 4/5 on the manual muscle test AND a score of
≥1 and ≤ 11/14 on the hand section of the upper extremity Fugl-Meyer Assessment
Skin intact on hemiparetic arm, hand and scalp
While relaxed, surface neuromuscular electrical stimulation of finger extensors and thumb extensors and/or abductors produces a functional degree of hand opening without pain.
No significant visual or hearing impairment
Exclusion Criteria:
Co-existing neurological condition other than prior stroke involving the hemiparetic upper limb (e.g., peripheral nerve injury, Parkinson's disease, spinal cord injury, traumatic brain injury, multiple sclerosis).
Uncontrolled seizure disorder
Use of seizure lowering threshold medications at the discretion of the study physician (Dr. Rich Wilson)
Cardiac pacemaker or other implanted electronic device and/or stent
Pregnant
Intramuscular botox injections in any upper extremity muscle in the last 3 months
Insensate arm, forearm, or hand
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)
Metal implant in the head
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David A Cunningham, PhD
Phone
(216) 957-3349
Email
Dxc536@case.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David A Cunningham, PhD
Organizational Affiliation
MetroHealth Medical Center
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
David A Cunningham, PhD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data and results will be made available by request
Learn more about this trial
Improving Stroke Motor Control With Non-invasive Brain Stimulation and Functional Electrical Stimulation
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