Contralaterally Controlled FES Plus Transcranial Direct Current Stimulation for Hand Motor Control After Stroke: A Pilot Study

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

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

• 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

Locations
United States
Ohio
MetroHealth Medical Center
RECRUITING
Cleveland
Contact Information
Primary
David A Cunningham, PhD
Dxc536@case.edu
(216) 957-3349
Time Frame
Start Date: 2019-08-01
Estimated Completion Date: 2028-08-01
Participants
Target number of participants: 15
Treatments
Experimental: conventional tDCS concurrent with CCFES
tDCS anode placed over the lesioned hemisphere and cathode placed over the non-lesioned hemisphere
Experimental: unconventional tDCS concurrent with CCFES
tDCS cathode placed over the lesioned hemisphere and anode placed over the non-lesioned hemisphere
Experimental: conventional tDCS preceding CCFES
tDCS anode placed over the lesioned hemisphere and cathode placed over the non-lesioned hemisphere
Experimental: unconventional tDCS preceding CCFES
tDCS cathode placed over the lesioned hemisphere and anode placed over the non-lesioned hemisphere
Sham_comparator: sham tDCS with CCFES
sham tDCS preceding and concurrent with CCFES
Authors
Jayme S Knutson
Related Therapeutic Areas
Sponsors
Leads: MetroHealth Medical Center

This content was sourced from clinicaltrials.gov