Actively Recruiting

Phase Not Applicable
Age: 21Years - 90Years
All Genders
NCT05866003

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

Led by MetroHealth Medical Center · Updated on 2025-09-29

63

Participants Needed

1

Research Sites

248 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 21Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 21 to 90 years
  • Stroke occurred 6 to 24 months ago
  • Able to follow a 3-stage command
  • Able to remember 2 of 3 items after 30 minutes
  • Full voluntary movement of elbow and hand on unaffected side
  • Adequate active shoulder and elbow movement to position affected hand for tabletop tasks
  • Able to sit unassisted in an armless straight-back chair during screening
  • Medically stable
  • Finger and wrist extension of at least 10 degrees
  • Skin intact on affected arm, hand, and scalp
  • Muscle contraction can be triggered with Transcranial Magnetic Stimulation
  • Unilateral upper limb weakness with finger extensor strength grade 4/5 or less
  • Score between 1 and 11 on the hand section of the upper extremity Fugl-Meyer Assessment
  • Surface electrical stimulation produces functional hand opening without pain while relaxed
Not Eligible

You will not qualify if you...

  • Other neurological conditions affecting the affected upper limb (e.g., peripheral nerve injury, Parkinson's disease, spinal cord injury, traumatic brain injury, multiple sclerosis)
  • Uncontrolled seizure disorder
  • Use of seizure-threshold lowering medications as decided by study physician
  • Presence of cardiac pacemaker or other implanted electronic device
  • Pregnant
  • Botox injections in any upper extremity muscle within the last 3 months
  • Numbness or lack of sensation in affected arm, forearm, or hand
  • Communication difficulties that interfere with study participation
  • Severe cognitive or communication impairment
  • Uncompensated hemi-neglect (extinguishing to double simultaneous stimulation)
  • Severe shoulder or hand pain preventing hand positioning for tasks

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

MetroHealth Medical Center

Cleveland, Ohio, United States, 44109

Actively Recruiting

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Research Team

A

Amy Friedl, MS,OTR/L

CONTACT

D

David Cunningham, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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