Recovering Arm Function in Chronic Post-stroke Patients Using Combined HD-tDCS and Virtual Reality Therapy (ReArm)

September 24, 2025 updated by: University Hospital, Montpellier
The study aims to determine the added value of combining high-definition transcranial direct current stimulation (HD-tDCS) in a rehabilitation program based on virtual reality therapy (VRT) to potentiate the effects on neuroplasticity and further improve functional recovery of the arm in chronic stroke patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Stroke remains the leading cause of acquired disability in France. Moreover, even after the first 3 months of intense arm rehabilitation, 80% of chronic stroke patients don't use their paretic arm in activities of daily living.

To this day, despite notable developments, techniques of rehabilitation of the arm for chronic stroke patients are still insufficient. In this context, two promising stroke rehabilitation techniques are to be considered:

  • Virtual reality-based systems provide specific, intensive, repetitive and motivational therapy with real-time feedback of movement and performance which can promote activity-dependent brain neuroplasticity, and therefore functional arm recovery. Thus, virtual reality therapy (VRT), in addition to usual rehabilitation, would improve the function of the arm more effectively as well as daily activities.
  • Non-invasive transcranial direct current stimulation (tDCS) uses constant low intensity (2 mA) continuous electrical currents to modulate the excitability of cortical neurons. Because of its greater focality of neuromodulatory effect that promotes brain neuroplasticity, anodal HD-tDCS to the lesioned hemisphere can improve functional arm recovery after a stroke. In addition, the combined use of the HD-tDCS with a rehabilitation modality, such as constraint induced movement therapy, would potentiate the combined effects of both techniques.

Therefore, the investigators hypothesize that the combination of HD-tDCS in a rehabilitation program based on VRT would potentiate the effects on neuroplasticity and would further improve functional recovery of the paretic arm in chronic stroke patients

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34000
        • Montpellier hospital Lapeyronie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient aged 18 to 90
  • Patient with more than 3 months of a first cerebrovascular accident whatever the aetiology
  • Patient with paresis of the upper extremity (FM-UE ≥ 15)

Exclusion Criteria:

  • Failure to collect written informed consent after a period of reflection
  • Not be affiliated with a French social security scheme or beneficiary of such a scheme
  • Major deficit of the upper extremity (FM-UE <15)
  • History of epilepsy
  • Presence of a pacemaker or a metallic object implanted in the head
  • Pregnant or lactating
  • Severe neglect or attention deficit disorder (omission of more than 15 bells in the Bell's test)
  • Severe cognitive impairment (Mini Mental Score <24)
  • Aphasia with impairment of understanding (Boston Aphasia Quotient <4/5)
  • Under guardianship or curatorship
  • Protected by law

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: HD-tDCS and Virtual Reality Therapy
Patients will receive their usual rehabilitation program each day, which includes a conventional session (30min) and virtual reality therapy session (Armeo Spring) combined with real stimulation (30min) over 13 consecutive training days (3 weeks)
Device: HD-tDCS
Real stimulation (2mA, 20min) with anode on C3/C4 of the lesioned hemisphere and 4 return electrodes ~4cm away
Other Names:
  • Starstim8 (Neuroelectrics, Spain)
Sham Comparator: Sham stimulation and Virtual Reality Therapy
Patients will receive their usual rehabilitation program each day, which includes a conventional session (30min) and virtual reality therapy session (Armeo Spring) combined with Sham stimulation (30min) over 13 consecutive training days (3 weeks)
Device: Sham HD-tDCS
Sham stimulation (2mA, ramp up and down phases of 30s) with anode on C3/C4 of the lesioned hemisphere and 4 return electrodes ~4cm away
Other Names:
  • Starstim8 (Neuroelectrics, Spain)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Functional Motor capacity of the upper extremity
Time Frame: Change from Baseline at Day 21(after intervention) and 3 months after day 21
Arm functional capacity assessed by the Wolf Motor Function Test (WMFT) (0-75, where higher scores mean better arm functional capacity)
Change from Baseline at Day 21(after intervention) and 3 months after day 21
Change in Functional Motor capacity of the upper extremity
Time Frame: Change from Day 21 at 3 months (retention)
Arm functional capacity assessed by the Wolf Motor Function Test (WMFT) (0-75, where higher scores mean better arm functional capacity)
Change from Day 21 at 3 months (retention)
Change in Motor deficit of the upper extremity
Time Frame: Change from Baseline at Day 21 (after intervention) and 3 months after day 21
Measured by the Fugl-Meyer Upper Extremity (FMUE) score (0-66, where higher scores mean a better recovery)
Change from Baseline at Day 21 (after intervention) and 3 months after day 21
Change in Motor deficit of the upper extremity
Time Frame: Change from Day 21 at 3 months (retention)
Measured by the Fugl-Meyer Upper Extremity (FMUE) score (0-66, where higher scores mean a better recovery)
Change from Day 21 at 3 months (retention)
Change in Hand dexterity
Time Frame: Change in Baseline at Day 21 (after intervention) and 3 months after day 21
Measured by the Box and Block Test (BBT) score (greater number of blocks moved in 1minute means better hand dexterity)
Change in Baseline at Day 21 (after intervention) and 3 months after day 21
Change in Hand dexterity
Time Frame: Change in Day21 at 3 months (retention)
Measured by the Box and Block Test (BBT) score (greater number of blocks moved in 1minute means better hand dexterity)
Change in Day21 at 3 months (retention)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Non-use of the paretic upper extremity
Time Frame: Change from Baseline at Day 21 (after intervention) and 3 months after day 21
Measured by the Proximal Arm Non-Use (PANU) score during an arm reaching task (0-100 where higher scores mean a worse outcome)
Change from Baseline at Day 21 (after intervention) and 3 months after day 21
Change in Non-use of the paretic upper extremity
Time Frame: Change from Day 21 at 3 months (retention)
Measured by the Proximal Arm Non-Use (PANU) score during an arm reaching task (0-100 where higher scores mean a worse outcome)
Change from Day 21 at 3 months (retention)
Change in Activities of daily living
Time Frame: Change from Baseline at Day 21 (after intervention) and 3 months after day 21
Measured by the Barthel Index (0-100 where higher scores mean a better outcome)
Change from Baseline at Day 21 (after intervention) and 3 months after day 21
Change in Activities of daily living
Time Frame: Change from Day 21 at 3 months (retention)
Measured by the Barthel Index (0-100 where higher scores mean a better outcome)
Change from Day 21 at 3 months (retention)
The use of the paretic upper extremity in activities of daily living
Time Frame: Change from Baseline at Post (10 days after the intervention), and Post 3 months (10 days at 3 months post intervention)
Measured by the magnitude and ratio of arm movements over a 10-day period from wrist worn accelerometers on each arm
Change from Baseline at Post (10 days after the intervention), and Post 3 months (10 days at 3 months post intervention)
The use of each upper extremity in activities of daily living
Time Frame: Change from Post at Post 3 months (retention)
Measured by the magnitude and ratio of arm movements over a 10-day period from wrist worn accelerometers on each arm
Change from Post at Post 3 months (retention)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Interhemispheric Sensorimotor cortex haemodynamics (functional near-infrared spectroscopy-fNIRS)
Time Frame: Change from Baseline at Day 21 (after intervention)
Measured by the magnitude and ratio of the concentration of oxygenated haemoglobin in the ipsilesional and contralesional sensorimotor cortex at rest and during arm movements
Change from Baseline at Day 21 (after intervention)
Change in Interhemispheric Sensorimotor cortex haemodynamics (functional near-infrared spectroscopy-fNIRS)
Time Frame: Change from Day 21 at 3 months (retention)
Measured by the magnitude and ratio of the concentration of oxygenated haemoglobin in the ipsilesional and contralesional sensorimotor cortex at rest and during arm movements
Change from Day 21 at 3 months (retention)
Change in Interhemispheric Sensorimotor cortex neural oscillations (Electroencephalography- EEG)
Time Frame: Change from Baseline at Day 21 (after intervention)
Measured by the magnitude and ratio of alpha/beta frequency power in the ipsilesional and contralesional sensorimotor cortex at rest and during arm movements
Change from Baseline at Day 21 (after intervention)
Change in Interhemispheric Sensorimotor cortex neural oscillations (Electroencephalography- EEG)
Time Frame: Change from Day 21 at 3 months (retention)
Measured by the magnitude and ratio of alpha/beta frequency power in the ipsilesional and contralesional sensorimotor cortex at rest and during arm movements
Change from Day 21 at 3 months (retention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Collaborators

Université Montpellier
Groupement Interrégional de Recherche Clinique et d'Innovation
IMT Mines Alès

Investigators

  • Principal Investigator: Karima KA Bakhti, PhD, Montpellier hospital Lapeyronie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Actual)

March 26, 2025

Study Completion (Actual)

March 26, 2025

Study Registration Dates

First Submitted

January 3, 2020

First Submitted That Met QC Criteria

February 27, 2020

First Posted (Actual)

March 2, 2020

Study Record Updates

Last Update Posted (Estimated)

September 30, 2025

Last Update Submitted That Met QC Criteria

September 24, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECHMPL19_0080
  • 2019-A00506-51 (Registry Identifier: ID-RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data available upon request through a data access

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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