tDCS During Contralaterally Controlled FES for Upper Extremity Hemiplegia

Status: Recruiting
Location: See location...
Intervention Type: Device, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 90
Healthy Volunteers: f
View:

• Age ≥ 21 and ≤ 90

• ≥ 6 and ≤ 24 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.

Locations
United States
Ohio
MetroHealth Medical Center
RECRUITING
Cleveland
Contact Information
Primary
Amy Friedl, MS,OTR/L
strokeresearch@metrohealth.org
216-957-3598
Backup
David Cunningham, PhD
dxc536@case.edu
216-957-3349
Time Frame
Start Date: 2023-07-01
Estimated Completion Date: 2028-04
Participants
Target number of participants: 63
Treatments
Active_comparator: Active conventional tDCS plus CCFES
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.
Active_comparator: Active unconventional tDCS plus CCFES
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.
Sham_comparator: Sham tDCS plus CCFES
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.
Sponsors
Leads: MetroHealth Medical Center

This content was sourced from clinicaltrials.gov