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

Official title

tDCS During Contralaterally Controlled FES for Upper Extremity Hemiplegia

Overview

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.

Detailed 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.

Interventions

• 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
• Device 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
• Device 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.

Primary outcome measures

• Box and Blocks Test (BBT) [Time frame: Change in BBT will be assessed at 6 weeks, 12 weeks, 24 weeks, and 36 weeks]

Secondary outcome measures (1)

• Upper Extremity Fugl-Meyer Assessment (UEFM). [Time frame: Change in UEFM will be assessed at 6 weeks, 12 weeks, 24 weeks, and 36 weeks]

Eligibility criteria

Inclusion criteria

• Age ≥ 21 and ≤ 90
• ≥ 6 and ≤ 24 months since first clinical hemorrhagic or nonhemorrhagic stroke
• Able to follow 3-stage command
• Able to remember 2 of 3 items after 30 minutes
• Full volitional elbow extension/flexion and hand opening/closing of unaffected limb
• Adequate active movement of shoulder and elbow to position the paretic hand in the workspace for table-top task practice
• Patient must be able to sit unassisted in an armless straight-back chair for the duration of the screening portion of the eligibility assessment
• Medically stable
• ≥ 10° finger and wrist extension
• Skin intact on hemiparetic arm, hand and scalp
• Muscle contraction can be elicited with Transcranial Magnetic Stimulation
• Unilateral upper limb hemiparesis with finger extensor strength of ≤ grade 4/5 on the Medical Research Council (MRC) scale
• Score of ≥1/14 and ≤ 11/14 on the hand section of the upper extremity Fugl-Meyer Assessment
• While relaxed, surface NMES of finger extensors and thumb extensors and/or abductors produces a functional degree of hand opening without pain.

Exclusion criteria

• Co-existing neurological condition other than prior stroke involving the hemiparetic upper limb (e.g., peripheral nerve injury, PD, SCI, TBI, MS).
• Uncontrolled seizure disorder
• Use of seizure lowering threshold medications and the discretion of the study physician
• Cardiac pacemaker or other implanted electronic device
• Pregnant
• IM Botox injections in any UE muscle in the last 3 months
• Insensate arm, forearm, or hand
• Deficits in communication that interfere with reasonable study participation
• Severely impaired cognition and communication
• Uncompensated hemi-neglect (extinguishing to double simultaneous stimulation)
• Severe shoulder or hand pain (unable to position hand in the workspace without pain)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

United States · 1 center

• MetroHealth Medical Center — Cleveland

Identifiers

NCT: NCT05866003 · STUDY00000229

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗