NCT03562663

Brain Stimulation and Robotics in Chronic Stroke Motor Recovery

Transcranial Direct Current Stimulation and Robotic Training in Chronic Stroke

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Burke Medical Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Motor skill training and transcranial direct current stimulation (tDCS) have separately been shown to alter cortical excitability and enhance motor function in humans. Their combination is appealing for augmenting motor recovery in stroke patients, and this is an area presently under heavy investigation globally. The investigators have previously shown that the timing of tDCS application has functional significance, that tDCS applied prior to training can be beneficial for voluntary behavior, and that tDCS effects may not simply be additive to training effects, but may change the nature of the training effect. The investigators have separately reported in a randomized-controlled clinical trial, that upper limb robotic training alone over 12 weeks can improve clinical function of chronic stroke patients. Based on our results with tDCS and robotic training, the investigators hypothesize that the same repeated sessions of robotic training, but preceded by tDCS, would lead to a sustained and functional change greater than robotic training alone. The investigators will determine if clinical function can be improved and sustained with tDCS-robotic training and cortical physiology changes that underlie functional improvements.

Detailed description

The primary aim of this study is to evaluate whether multiple sessions of combined tDCS and robotic upper limb training in chronic hemiplegia, leads to clinical improvement in upperlimb motor impairment. In chronic stroke patients (\>6months post-injury, stable unilateral motor deficit) using a within-subjects repeated-measures design we will evaluate the effects of 12 weeks of robotic upperlimb training (3x/week, 36 sessions, shoulder/elbow/wrist in each session) with real or sham tDCS before the robotic training. Clinical improvement will be determined by a change in upper-limb Fugl-Meyer (primary), the Medical Research Council motor power score (MRC), Wolf Motor Function Test, Barthel Index, and Stroke Impact Scale (secondary) outcome measures following the training, and assessed again six months later. The investigators further aim to identify and compare the neurophysiological characteristics between intervention groups. The relationship between clinical improvement and neurophysiological measures pertaining to robotic motor training following stroke are presently not described in the literature. By measuring the EMG response from forearm musculature to Transcranial Magnetic Stimulation the investigators will establish: (i) plasticity associated with training, and (ii) the neurophysiological characteristics of patients who respond to training. By understanding how brain excitability changes underpin motor dysfunction, and motor recovery, interventions can be more effectively prescribed and prognoses established.

Conditions

• Chronic Stroke

Interventions

Type	Name	Description
DEVICE	Transcranial direct current stimulation	A constant, low current stimulation is provided non-invasively through sponge electrodes positioned over the motor cortex of the affected arm. The stimulation is provided for 20 minutes at an intensity of 2 mA.
DEVICE	Upper extremity robotics	Participants complete robotic training 3 days per week for 12 weeks, or 36 sessions. The protocol alternates between planar (shoulder/elbow) and wrist robots for the duration of the study.

Timeline

• Start date: 2012-01-01
• Primary completion: 2016-01-01
• Completion: 2016-12-01
• First posted: 2018-06-19
• Last updated: 2021-01-20
• Results posted: 2021-01-20

Regulatory

• FDA-regulated device study