RECRUITING

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

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Conditions

StrokeUpper Extremity ParesisHemiplegiaRehabilitationTherapyElectrical StimulationBrain stimulationHandCCFESMotor CortexTMSMotor RecoveryCentral Nervous SystemCVAUpper Limb

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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

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.

Official Title

tDCS During Contralaterally Controlled FES for Upper Extremity Hemiplegia

Quick Facts

Study Start:2023-07-01
Study Completion:2028-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05866003

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 to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age ≥ 21 and ≤ 90
  2. 2. ≥ 6 and ≤ 24 months since first clinical hemorrhagic or nonhemorrhagic stroke
  3. 3. Able to follow 3-stage command
  4. 4. Able to remember 2 of 3 items after 30 minutes
  5. 5. Full volitional elbow extension/flexion and hand opening/closing of unaffected limb
  6. 6. Adequate active movement of shoulder and elbow to position the paretic hand in the workspace for table-top task practice
  7. 7. Patient must be able to sit unassisted in an armless straight-back chair for the duration of the screening portion of the eligibility assessment
  8. 8. Medically stable
  9. 9. ≥ 10° finger and wrist extension
  10. 10. Skin intact on hemiparetic arm, hand and scalp
  11. 11. Muscle contraction can be elicited with Transcranial Magnetic Stimulation
  12. 12. Unilateral upper limb hemiparesis with finger extensor strength of ≤ grade 4/5 on the Medical Research Council (MRC) scale
  13. 13. Score of ≥1/14 and ≤ 11/14 on the hand section of the upper extremity Fugl-Meyer Assessment
  14. 14. While relaxed, surface NMES of finger extensors and thumb extensors and/or abductors produces a functional degree of hand opening without pain.
  1. 1. Co-existing neurological condition other than prior stroke involving the hemiparetic upper limb (e.g., peripheral nerve injury, PD, SCI, TBI, MS).
  2. 2. Uncontrolled seizure disorder
  3. 3. Use of seizure lowering threshold medications and the discretion of the study physician
  4. 4. Cardiac pacemaker or other implanted electronic device
  5. 5. Pregnant
  6. 6. IM Botox injections in any UE muscle in the last 3 months
  7. 7. Insensate arm, forearm, or hand
  8. 8. Deficits in communication that interfere with reasonable study participation
  9. 9. Severely impaired cognition and communication
  10. 10. Uncompensated hemi-neglect (extinguishing to double simultaneous stimulation)
  11. 11. Severe shoulder or hand pain (unable to position hand in the workspace without pain)

Contacts and Locations

Study Contact

Amy Friedl, MS,OTR/L
CONTACT
216-957-3598
strokeresearch@metrohealth.org
David Cunningham, PhD
CONTACT
216-957-3349
dxc536@case.edu

Principal Investigator

David A Cunningham, PhD
PRINCIPAL_INVESTIGATOR
MetroHealth Medical Center and Case Western Reserve University

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 and Case Western Reserve University

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 Date2023-07-01
Study Completion Date2028-04

Study Record Updates

Study Start Date2023-07-01
Study Completion Date2028-04

Terms related to this study

Keywords Provided by Researchers

  • Stroke
  • Rehabilitation
  • Therapy
  • Electrical Stimulation
  • Brain stimulation
  • Hand
  • CCFES
  • Motor Cortex
  • TMS
  • Motor Recovery
  • Central Nervous System
  • CVA
  • Upper Limb

Additional Relevant MeSH Terms

  • Stroke
  • Upper Extremity Paresis
  • Hemiplegia