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

Stroke Clinical Trial

Official title:

tDCS During Contralaterally Controlled FES for Upper Extremity Hemiplegia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05866003
• Other study ID #: STUDY00000229
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: April 2028

Study information

• Verified date: November 2023
• Source: MetroHealth Medical Center
• Contact: Amy Friedl, MS,OTR/L
• Phone: 2169573581
• Email: afriedl[@]metrohealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

This study is a randomized clinical trail (RCT) of stroke survivors with chronic (6 to 24 months) hemiplegia randomized to: 1) conventional transcranial direct current stimulation (tDCS), 2) unconventional tDCS, or 3) sham tDCS during contralaterally controlled functional electrical stimulation mediated occupational therapy. The treatment will last 12 weeks and be followed by a 6-month follow-up period. Assessors, therapists and participants will be blinded to which tDCS treatment is received. This will be the first RCT of tDCS + CCFES.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 63
• Est. completion date: April 2028
• Est. primary completion date: April 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Age = 21 and = 90

2. = 6 and = 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. = 10° 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 = grade 4/5 on the Medical Research Council (MRC) scale

13. Score of =1/14 and = 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)

Related Conditions & MeSH terms

• Hemiplegia
• Paresis
• Stroke
• Upper Extremity Paresis

Intervention

Device:
• Active conventional tDCS montage plus CCFES
tDCS is a non-invasive brain stimulation technique. A small machine (9-volt battery operated device) will use a weak amount of electric current to stimulate the brain without any invasive procedure. Electrodes, covered in sponges soaked in saline, will be placed over certain parts of your head and held in place using a rubber strap. In addition, an electrical stimulator will be used to deliver electrical current through surface electrodes to produce hand opening by making the paretic finger and thumb extensor muscles contract.
• Active unconventional tDCS montage plus CCFES
tDCS is a non-invasive brain stimulation technique. A small machine (9-volt battery operated device) will use a weak amount of electric current to stimulate the brain without any invasive procedure. Electrodes, covered in sponges soaked in saline, will be placed over certain parts of your head and held in place using a rubber strap. In addition, An electrical stimulator will be used to deliver electrical current through surface electrodes to produce hand opening by making the paretic finger and thumb extensor muscles contract.
• Sham tDCS plus CCFES
An electrical stimulator will be used to deliver electrical current through surface electrodes to produce hand opening by making the paretic finger and thumb extensor muscles contract. The stimulator can be programmed to deliver stimulation with an intensity that corresponds to the opening of a glove instrumented with sensors and plugged into the stimulator.

Behavioral:
• CCFES with Occupational Therapy
An electrical stimulator will be used to deliver electrical current through surface electrodes to produce hand opening by making the paretic finger and thumb extensor muscles contract. The stimulator can be programmed to deliver stimulation with an intensity that corresponds to the opening of a glove instrumented with sensors and plugged into the stimulator. During the lab visits, all participants will use CCFES to assist hand opening during occupational therapy task practice.

Locations

Country	Name	City	State
United States	MetroHealth Medical Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
MetroHealth Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Neurophysiologic Assessments	Neurophysiologic assessments will be performed using TMS. Measures of excitability and inhibition will be measured.	Change in neurophysiologic assessments will be assessed at 6 weeks, 12 weeks, 24 weeks, and 36 weeks
Primary	Box and Blocks Test (BBT)	The BBT counts how many blocks a patient can pick up, move over a barrier, and release in 60 seconds.	Change in BBT will be assessed at 6 weeks, 12 weeks, 24 weeks, and 36 weeks
Secondary	Upper Extremity Fugl-Meyer Assessment (UEFM).	The UEFM is a reliable and valid measure of post-stroke upper limb motor impairment	Change in UEFM will be assessed at 6 weeks, 12 weeks, 24 weeks, and 36 weeks