๐ฌIn plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
1. Age โฅ 21 and โค 90
2. โฅ 6 and โค 24 months since first clinical hemorrhagic or nonhemorrhagic stroke
3. Able to follow 3-stage command
4. Able to remember 2 of 3 items after 30 minutes
5. Full volitional elbow extension/flexion and hand opening/closing of unaffected limb
6. Adequate active movement of shoulder and elbow to position the paretic hand in the workspace for table-top task practice
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. Medically stable
9. โฅ 10ยฐ finger and wrist extension
10. Skin intact on hemiparetic arm, hand and scalp
11. Muscle contraction can be elicited with Transcranial Magnetic Stimulation
12. Unilateral upper limb hemiparesis with finger extensor strength of โค grade 4/5 on the Medical Research Council (MRC) scale
13. Score of โฅ1/14 and โค 11/14 on the hand section of the upper extremity Fugl-Meyer Assessment
14. While relaxed, surface NMES of finger extensors and thumb extensors and/or abductors produces a functional degree of hand opening without pain.
Exclusion Criteria:
1. Co-existing neurological condition other than prior stroke involving the hemiparetic upper limb (e.g., peripheral nerve injury, PD, SCI, TBI, MS).
2. Uncontrolled seizure disorder
3. Use of seizure lowering threshold medications and the discretion of the study physician
4. Cardiac pacemaker or other implanted electronic device
5. Pregnant
6. IM Botox injections in any UE muscle in the last 3 months
7. Insensate arm, forearm, or hand
8. Deficits in communication that interfere with reasonable study participation
9. Severely impaired cognition and communication
10. Uncompensated hemi-neglect (extinguishing to double simultaneous stimulation)
11. Severe shoulder or hand pain (unable to position hand in the workspace without pain)
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What it tests
- Active conventional tDCS montage plus CCFES
- Active unconventional tDCS montage plus CCFES
- Sham tDCS plus CCFES
- CCFES with Occupational Therapy
MetroHealth Medical Center
Cleveland, United States
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.