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Completed

NCT Number: NCT04291573

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

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Montpellier hospital Lapeyronie

Montpellier, 34000, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HD-tDCS

Device

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 HD-tDCS

Device

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)

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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

  6. 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

Other outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

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

Registry information

Acronym: ReArm

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Mar 2, 2020
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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