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

NCT04291573 | Completed DMC

• 2 other identifiers: RECHMPL19_00802019-A00506-51
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Post Stroke Individuals

Keywords

Stroke; HD-tDCS; Virtual Reality Therapy; Physical therapy

Outcome Measures

Primary Outcomes (6)

• Change in Functional Motor capacity of the upper extremity

  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

  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

  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

  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

  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

  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 Outcomes (6)

• Change in Non-use of the paretic upper extremity

  Change from Baseline at Day 21 (after intervention) and 3 months after day 21

• Change in Non-use of the paretic upper extremity

  Change from Day 21 at 3 months (retention)

• Change in Activities of daily living

  Change from Baseline at Day 21 (after intervention) and 3 months after day 21

• Change in Activities of daily living

  Change from Day 21 at 3 months (retention)

• The use of the paretic upper extremity in activities of daily living

  Change from Baseline at Post (10 days after the intervention), and Post 3 months (10 days at 3 months post intervention)

Other Outcomes (4)

• Change in Interhemispheric Sensorimotor cortex haemodynamics (functional near-infrared spectroscopy-fNIRS)

  Change from Baseline at Day 21 (after intervention)

• Change in Interhemispheric Sensorimotor cortex haemodynamics (functional near-infrared spectroscopy-fNIRS)

  Change from Day 21 at 3 months (retention)

• Change in Interhemispheric Sensorimotor cortex neural oscillations (Electroencephalography- EEG)

  Change from Baseline at Day 21 (after intervention)

Study Arms (2)

HD-tDCS and Virtual Reality Therapy

ACTIVE COMPARATOR

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

Sham stimulation and Virtual Reality Therapy

SHAM COMPARATOR

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

Interventions

HD-tDCS DEVICE

Real stimulation (2mA, 20min) with anode on C3/C4 of the lesioned hemisphere and 4 return electrodes \~4cm away

Also known as: Starstim8 (Neuroelectrics, Spain)

HD-tDCS and Virtual Reality Therapy

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

Also known as: Starstim8 (Neuroelectrics, Spain)

Sham stimulation and Virtual Reality Therapy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• Université Montpellier: collaborator
• Groupement Interrégional de Recherche Clinique et d'Innovation: collaborator
• IMT Mines Alès: collaborator

Study Sites (1)

Montpellier hospital Lapeyronie

Montpellier, 34000, France

Location

Related Publications (14)

• Levin MF, Weiss PL, Keshner EA. Emergence of virtual reality as a tool for upper limb rehabilitation: incorporation of motor control and motor learning principles. Phys Ther. 2015 Mar;95(3):415-25. doi: 10.2522/ptj.20130579. Epub 2014 Sep 11.

  PMID: 25212522 BACKGROUND

• Laffont I, Bakhti K, Coroian F, van Dokkum L, Mottet D, Schweighofer N, Froger J. Innovative technologies applied to sensorimotor rehabilitation after stroke. Ann Phys Rehabil Med. 2014 Nov;57(8):543-551. doi: 10.1016/j.rehab.2014.08.007. Epub 2014 Aug 26.

  PMID: 25261273 BACKGROUND

• Laver KE, Lange B, George S, Deutsch JE, Saposnik G, Crotty M. Virtual reality for stroke rehabilitation. Cochrane Database Syst Rev. 2017 Nov 20;11(11):CD008349. doi: 10.1002/14651858.CD008349.pub4.

  PMID: 29156493 BACKGROUND

• Polania R, Nitsche MA, Ruff CC. Studying and modifying brain function with non-invasive brain stimulation. Nat Neurosci. 2018 Feb;21(2):174-187. doi: 10.1038/s41593-017-0054-4. Epub 2018 Jan 8.

  PMID: 29311747 BACKGROUND

• Bikson M, Grossman P, Thomas C, Zannou AL, Jiang J, Adnan T, Mourdoukoutas AP, Kronberg G, Truong D, Boggio P, Brunoni AR, Charvet L, Fregni F, Fritsch B, Gillick B, Hamilton RH, Hampstead BM, Jankord R, Kirton A, Knotkova H, Liebetanz D, Liu A, Loo C, Nitsche MA, Reis J, Richardson JD, Rotenberg A, Turkeltaub PE, Woods AJ. Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. Brain Stimul. 2016 Sep-Oct;9(5):641-661. doi: 10.1016/j.brs.2016.06.004. Epub 2016 Jun 15.

  PMID: 27372845 BACKGROUND

• Chhatbar PY, Chen R, Deardorff R, Dellenbach B, Kautz SA, George MS, Feng W. Safety and tolerability of transcranial direct current stimulation to stroke patients - A phase I current escalation study. Brain Stimul. 2017 May-Jun;10(3):553-559. doi: 10.1016/j.brs.2017.02.007. Epub 2017 Feb 27.

  PMID: 28279641 BACKGROUND

• Floel A. tDCS-enhanced motor and cognitive function in neurological diseases. Neuroimage. 2014 Jan 15;85 Pt 3:934-47. doi: 10.1016/j.neuroimage.2013.05.098. Epub 2013 May 30.

  PMID: 23727025 BACKGROUND

• Teo WP, Muthalib M, Yamin S, Hendy AM, Bramstedt K, Kotsopoulos E, Perrey S, Ayaz H. Does a Combination of Virtual Reality, Neuromodulation and Neuroimaging Provide a Comprehensive Platform for Neurorehabilitation? - A Narrative Review of the Literature. Front Hum Neurosci. 2016 Jun 24;10:284. doi: 10.3389/fnhum.2016.00284. eCollection 2016.

  PMID: 27445739 BACKGROUND

• Allman C, Amadi U, Winkler AM, Wilkins L, Filippini N, Kischka U, Stagg CJ, Johansen-Berg H. Ipsilesional anodal tDCS enhances the functional benefits of rehabilitation in patients after stroke. Sci Transl Med. 2016 Mar 16;8(330):330re1. doi: 10.1126/scitranslmed.aad5651. Epub 2016 Mar 16.

  PMID: 27089207 BACKGROUND

• Bakhti KKA, Laffont I, Muthalib M, Froger J, Mottet D. Kinect-based assessment of proximal arm non-use after a stroke. J Neuroeng Rehabil. 2018 Nov 14;15(1):104. doi: 10.1186/s12984-018-0451-2.

  PMID: 30428896 BACKGROUND

• Chhatbar PY, Ramakrishnan V, Kautz S, George MS, Adams RJ, Feng W. Transcranial Direct Current Stimulation Post-Stroke Upper Extremity Motor Recovery Studies Exhibit a Dose-Response Relationship. Brain Stimul. 2016 Jan-Feb;9(1):16-26. doi: 10.1016/j.brs.2015.09.002. Epub 2015 Sep 7.

  PMID: 26433609 BACKGROUND

• Figlewski K, Blicher JU, Mortensen J, Severinsen KE, Nielsen JF, Andersen H. Transcranial Direct Current Stimulation Potentiates Improvements in Functional Ability in Patients With Chronic Stroke Receiving Constraint-Induced Movement Therapy. Stroke. 2017 Jan;48(1):229-232. doi: 10.1161/STROKEAHA.116.014988. Epub 2016 Nov 29.

  PMID: 27899754 BACKGROUND

• Dusfour G, Mottet D, Muthalib M, Laffont I, Bakhti K. Comparison of wrist actimetry variables of paretic upper limb use in post stroke patients for ecological monitoring. J Neuroeng Rehabil. 2023 Apr 27;20(1):52. doi: 10.1186/s12984-023-01167-y.

  PMID: 37106460 DERIVED

• Muller CO, Muthalib M, Mottet D, Perrey S, Dray G, Delorme M, Duflos C, Froger J, Xu B, Faity G, Pla S, Jean P, Laffont I, Bakhti KKA. Recovering arm function in chronic stroke patients using combined anodal HD-tDCS and virtual reality therapy (ReArm): a study protocol for a randomized controlled trial. Trials. 2021 Oct 26;22(1):747. doi: 10.1186/s13063-021-05689-5.

  PMID: 34702317 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Karima KA Bakhti, PhD

  Montpellier hospital Lapeyronie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2020
• First Posted: March 2, 2020
• Study Start: February 1, 2021
• Primary Completion: March 26, 2025
• Study Completion: March 26, 2025
• Last Updated: September 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

FR (1)