Combined Transcranial Direct Current Stimulation and Motor Imagery-based Robotic Arm Training for Stroke Rehabilitation

NCT01897025 | Completed Phase 2 Results

• 1 other identifier: NIG09may022
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Stroke is the most common cause of adult disability. Current treatments for functional loss of the upper extremity post-stroke remain limited in efficacy, particularly for those with moderate to severe impairment. Previous studies have demonstrated the efficacy of transcranial direct current stimulation (tDCS) for motor recovery post-stroke, a technique of neuromodulation. Motor imagery is effective to enhance motor recovery, with activation of neural pathways similar to that of motor execution. This treatment is accessible to more severely impaired stroke survivors. Our previous studies have demonstrated feasibility and efficacy of motor imagery-based brain computer interface (MI-BCI) for post-stroke motor impairment, in which motor imagery is detected by surface EEG and translated to execution of the target movement with the aid of an arm robot (MIT-Manus). In this study, we investigate the feasibility of combining robot-assisted MI-BCI training, with tDCS to facilitate post-stroke motor recovery in moderate to severe impairment of upper extremity function. We hypothesise that both tDCS-BCI and sham-BCI will improve motor function in the stroke-affected arm; but that tDCS-BCI will be more effective than sham-BCI. Our secondary aim is to gain insight into the neurophysiological mechanism by comparing the cortical excitability changes following sham-BCI vs tDCS-BCI, using transcranial magnetic stimulation (TMS). We will conduct a randomized, double-blinded study with MI-BCI combined with tDCS (tDCS-BCI) vs MI-BCI combined with sham-tDCS (sham tDCS-BCI). Subjects will undergo 10 sessions of tDCS each lasting 20 minutes, followed by 40 minutes of robot-assisted MI-BCI training at each session. Primary outcome will be functional ability measured by upper extremity component of the Fugl-Meyer Assessment. Secondary outcome measures will be the Box \& Block Test, Modified Ashworth Score (measuring spasticity), grip strength and measures of brain activity including transcranial magnetic stimulation (TMS) measures of magnetic resonance imaging (MRI) measures including functional MRI and diffusion tensor imaging (DTI). This study will be important to develop a new and effective treatment (tDCS-BCI) for post-stroke motor impairment.

Conditions

Stroke

Keywords

Stroke; Noninvasive brain stimulation; Brain-computer interface; Motor imagery; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Upper Extremity Component of Fugl-Meyer Assessment

  The total FMA score (range, 0-66) on the stroke-impaired upper extremity was used to measure the motor improvements in this study. Higher score indicates better upper limb motor function. FMA were measured at 3 time points: at baseline (wk 0), at completion of intervention (wk 2), and at a 2-week follow-up (wk 4).

  week 0, week 2, week 4

Secondary Outcomes (4)

• Resting Motor Threshold of Stroke Affected M1 Motor Cortex

  pre- and post-training, 4 weeks post-training

• Grip Strength

  pre- and post-training, and again at 4 weeks post-training

• Box and Block Test

  pre and post training, and 4 weeks post training

• MRI Parameters

  -2, 0 and 4 weeks

Study Arms (2)

real-tDCS with MI-BCI

ACTIVE COMPARATOR

10 sessions of the following: 20 minutes of tDCS prior to each session of motor training with the MI-BCI system. Direct current at an intensity of 1mA with anode placed over the M1 motor cortex of the affected hemisphere and the cathode placed over the unaffected M1. After initial calibration, MI-BCI training will involve motor imagery of reaching tasks using the clock game interface of the MIT-Manus robotic system to perform multi-directional reaching movements. Upon detection of the intention to move towards the target on BCI, the robotic arm will complete the reaching movement towards the target. Each training session will last for 40 minutes excluding set-up time.

Device: real-tDCS with MI-BCI

sham-tDCS with MI-BCI

SHAM COMPARATOR

10 sessions of sham tDCS with BCI motor training, each session of which will be conducted as follows: The same electrode placement and stimulation parameters will be employed for sham tDCS as for real tDCS. However, the current will be applied for 30 seconds only, to give subjects the sensation of the stimulation. This method of sham stimulation has also been validated (Gandiga et al., 2006). Current intensity will be increased and decreased gradually to decrease perception. MI-BCI training will be the same as the real-tDCS group and will similarly last for 40 minutes.

Device: real-tDCS with MI-BCI

Interventions

real-tDCS with MI-BCI DEVICE

As in Arm Description

real-tDCS with MI-BCI; sham-tDCS with MI-BCI

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• first ever haemorrhagic or ischaemic subcortical stroke more than 9 months prior to study enrollment
• upper extremity impairment of 11-45 on the Fugl-Meyer assessment scale

You may not qualify if:

• epilepsy
• neglect
• cognitive impairment
• other neurological or psychiatric diseases
• severe arm pain
• spasticity score \>2 on the Modified Ashworth Scale in the shoulder or elbow
• contraindications to TMS or tDCS (cranial implants, ventricular shunts, pacemakers, intrathecal pumps)
• grip strength \<10kg as measured by a dynamometer
• participation in other interventions or trials targeting stroke motor recovery.

Sponsors & Collaborators

• National University Hospital, Singapore: lead
• National University Health System, Singapore: collaborator
• Agency for Science, Technology and Research: collaborator

Study Sites (1)

National University Hospital

Singapore, Singapore, 119074, Singapore

Location

Related Publications (3)

• Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.

  PMID: 33175411 DERIVED

• Chew E, Teo WP, Tang N, Ang KK, Ng YS, Zhou JH, Teh I, Phua KS, Zhao L, Guan C. Using Transcranial Direct Current Stimulation to Augment the Effect of Motor Imagery-Assisted Brain-Computer Interface Training in Chronic Stroke Patients-Cortical Reorganization Considerations. Front Neurol. 2020 Aug 27;11:948. doi: 10.3389/fneur.2020.00948. eCollection 2020.

  PMID: 32973672 DERIVED

• Ang KK, Guan C, Phua KS, Wang C, Zhao L, Teo WP, Chen C, Ng YS, Chew E. Facilitating effects of transcranial direct current stimulation on motor imagery brain-computer interface with robotic feedback for stroke rehabilitation. Arch Phys Med Rehabil. 2015 Mar;96(3 Suppl):S79-87. doi: 10.1016/j.apmr.2014.08.008.

  PMID: 25721551 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Dr Effie Chew
• Organization: National University Hospital

effie_chew@nuhs.edu.sg

65-67726198

Study Officials

• Effie Chew, MBBS

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2013
• First Posted: July 11, 2013
• Study Start: January 1, 2011
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: March 10, 2016
• Results First Posted: March 10, 2016

Record last verified: 2016-02

Locations

SG (1)