# tDCS During Contralaterally Controlled FES for Upper Extremity Hemiplegia

> **NIH NIH R01** · CASE WESTERN RESERVE UNIVERSITY · 2024 · $682,416

## Abstract

PROJECT SUMMARY / ABSTRACT
Hemiparesis of the upper-limb is one of the most serious impairments resulting from stroke. Paresis of finger
and thumb extensors is a frequently persisting consequence of stroke, and causes loss of hand function. We
have developed contralaterally controlled functional electrical stimulation (CCFES), a novel neuromuscular
electrical stimulation (NMES) therapy that gives the patient intimate control of both timing and intensity of
stimulation to their finger and thumb extensors and thereby enables intention-driven hand opening and enhanced
functional task practice. Several clinical trials of CCFES-assisted therapy have shown that it reduces impairment
and improves function of the affected upper-limb, and it improves dexterity more than conventional NMES. The
main objective of this study is to build upon the benefits of CCFES-assisted therapy for chronic stroke motor
recovery. One strategy to improve rehabilitation outcomes is to combine treatments that may have synergistic
effects. Therefore, this study applies transcranial direct current stimulation (tDCS) to the motor cortex during
CCFES to determine if the combination of the two will improve outcomes over those achieved by CCFES alone.
TDCS and CCFES may work in synergy to improve outcomes by increasing the concurrent activity of the cortical
neurons within the ipsilesional motor network (conventional tDCS montage) or by exciting the contralesional
networks (unconventional tDCS montage), as suggested by our pilot single-session cross-over study. The
specific aims of the study are: 1) Determine if the addition of tDCS during CCFES improves motor outcomes
over CCFES alone, 2) Estimate the relative effects of two tDCS electrode arrangements on motor outcomes,
and 3) Estimate the relative effects of two tDCS electrode arrangements on neurophysiologic outcomes. We will
conduct a randomized controlled trial in which 63 stroke survivors 6 to 24 months post-stroke will be randomly
assigned to 12 weeks of: a) conventional tDCS during CCFES, b) unconventional tDCS during CCFES, or c)
sham tDCS during CCFES.
Upper extremity impairment, activity limitation and neurophysiologic assessment will
be made at baseline, 6, 12, 24, and 36 weeks. This study is the first RCT of tDCS during CCFES in chronic
upper extremity hemiplegia. The information learned in this study will serve to accelerate the development of
treatments for reducing post-stroke disability.

## Key facts

- **NIH application ID:** 10828431
- **Project number:** 5R01HD109299-02
- **Recipient organization:** CASE WESTERN RESERVE UNIVERSITY
- **Principal Investigator:** David Arthur Cunningham
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $682,416
- **Award type:** 5
- **Project period:** 2023-05-01 → 2028-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10828431

## Citation

> US National Institutes of Health, RePORTER application 10828431, tDCS During Contralaterally Controlled FES for Upper Extremity Hemiplegia (5R01HD109299-02). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/10828431. Licensed CC0.

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