RECRUITING

Improving Stroke Motor Control With Non-invasive Brain Stimulation and Functional Electrical Stimulation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2019-08-01

Study Completion:2026-08-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03857529

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Age ≥ 21 2. ≥ 6 months since first clinical hemorrhagic or nonhemorrhagic stroke 3. Able to follow 3-stage commands and remember 2 of 3 items after 30 minutes 4. Full volitional elbow extension/flexion and hand opening/closing of unaffected limb 5. Adequate active movement of shoulder and elbow to position the paretic hand in the workspace for table-top task practice 6. Patient must be able to sit unassisted in an armless straight-back chair for the duration of the screening portion of the eligibility assessment 7. Medically stable 8. ≥ 10° finger extension 9. Unilateral upper limb hemiparesis with finger extensor strength of ≤ grade 4/5 on the manual muscle test AND a score of 10. Skin intact on hemiparetic arm, hand and scalp 11. While relaxed, surface neuromuscular electrical stimulation of finger extensors and thumb extensors and/or abductors produces a functional degree of hand opening without pain. 12. No significant visual or hearing impairment	1. 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). 2. Uncontrolled seizure disorder 3. Use of seizure lowering threshold medications at the discretion of the study physician (Dr. Rich Wilson) 4. Cardiac pacemaker or other implanted electronic device and/or stent 5. Pregnant 6. Intramuscular botox injections in any upper extremity muscle in the last 3 months 7. Insensate arm, forearm, or hand 8. Severely impaired cognition and communication 9. Uncompensated hemi-neglect (extinguishing to double simultaneous stimulation) 10. Severe shoulder or hand pain (unable to position hand in the workspace without pain) 11. Metal implant in the head

Inclusion Criteria

Exclusion Criteria

1. Age ≥ 21
2. ≥ 6 months since first clinical hemorrhagic or nonhemorrhagic stroke
3. Able to follow 3-stage commands and remember 2 of 3 items after 30 minutes
4. Full volitional elbow extension/flexion and hand opening/closing of unaffected limb
5. Adequate active movement of shoulder and elbow to position the paretic hand in the workspace for table-top task practice
6. Patient must be able to sit unassisted in an armless straight-back chair for the duration of the screening portion of the eligibility assessment
7. Medically stable
8. ≥ 10° finger extension
9. Unilateral upper limb hemiparesis with finger extensor strength of ≤ grade 4/5 on the manual muscle test AND a score of
10. Skin intact on hemiparetic arm, hand and scalp
11. While relaxed, surface neuromuscular electrical stimulation of finger extensors and thumb extensors and/or abductors produces a functional degree of hand opening without pain.
12. No significant visual or hearing impairment

1. 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).
2. Uncontrolled seizure disorder
3. Use of seizure lowering threshold medications at the discretion of the study physician (Dr. Rich Wilson)
4. Cardiac pacemaker or other implanted electronic device and/or stent
5. Pregnant
6. Intramuscular botox injections in any upper extremity muscle in the last 3 months
7. Insensate arm, forearm, or hand
8. Severely impaired cognition and communication
9. Uncompensated hemi-neglect (extinguishing to double simultaneous stimulation)
10. Severe shoulder or hand pain (unable to position hand in the workspace without pain)
11. Metal implant in the head

Contacts and Locations

Study Contact

David A Cunningham, PhD

CONTACT

(216) 957-3349

Dxc536@case.edu

Principal Investigator

David A Cunningham, PhD

PRINCIPAL_INVESTIGATOR

MetroHealth Medical Center

Study Locations (Sites)

MetroHealth Medical Center

Cleveland, Ohio, 44109

United States

Collaborators and Investigators

Sponsor: MetroHealth Medical Center

David A Cunningham, PhD, PRINCIPAL_INVESTIGATOR, MetroHealth Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-08-01

Study Completion Date2026-08-01

Study Record Updates

Study Start Date2019-08-01

Study Completion Date2026-08-01

Terms related to this study

Additional Relevant MeSH Terms

Stroke
Rehabilitation
Hand