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Chronic Post Stroke IndividualsReArmNCT04291573

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

A study testing HD-tDCS in people with Chronic Post Stroke Individuals, run by University Hospital, Montpellier at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Chronic Post Stroke Individuals
What is being tested?
HD-tDCS
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
58 participants
Where
1 siteFrance
Study dates
1 Feb 2021to 26 Mar 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

France1 site
  • Montpellier hospital Lapeyronie

    Montpellier, 34000

Other trials in France

About this study

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.

Read the 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

Being tested
HD-tDCS, Sham HD-tDCS
Keywords
Stroke, HD-tDCS, Virtual Reality Therapy, Physical therapy
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HD-tDCSDevice

    Also called Starstim8 (Neuroelectrics, Spain)

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

  • Sham HD-tDCSDevice

    Also called Starstim8 (Neuroelectrics, Spain)

    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

Study groups in NCT04291573
Study groupRoleWhat they receive
HD-tDCS and Virtual Reality TherapyActive comparatorPatients 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)
Receives: Device: HD-tDCS
Sham stimulation and Virtual Reality TherapySham comparatorPatients 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)
Receives: Device: Sham HD-tDCS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

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

  2. 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)

    Measured: Change from Day 21 at 3 months (retention)

  3. 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)

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

  4. 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)

    Measured: Change from Day 21 at 3 months (retention)

  5. Change in Hand dexterity

    Measured by the Box and Block Test (BBT) score (greater number of blocks moved in 1minute means better hand dexterity)

    Measured: Change in Baseline at Day 21 (after intervention) and 3 months after day 21

  6. Change in Hand dexterity

    Measured by the Box and Block Test (BBT) score (greater number of blocks moved in 1minute means better hand dexterity)

    Measured: Change in Day21 at 3 months (retention)

Secondary outcomes (6)
  1. Change in Non-use of the paretic upper extremity

    Measured by the Proximal Arm Non-Use (PANU) score during an arm reaching task (0-100 where higher scores mean a worse outcome)

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

  2. Change in Non-use of the paretic upper extremity

    Measured by the Proximal Arm Non-Use (PANU) score during an arm reaching task (0-100 where higher scores mean a worse outcome)

    Measured: Change from Day 21 at 3 months (retention)

  3. Change in Activities of daily living

    Measured by the Barthel Index (0-100 where higher scores mean a better outcome)

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

  4. Change in Activities of daily living

    Measured by the Barthel Index (0-100 where higher scores mean a better outcome)

    Measured: Change from Day 21 at 3 months (retention)

  5. The use of the paretic upper extremity in activities of daily living

    Measured by the magnitude and ratio of arm movements over a 10-day period from wrist worn accelerometers on each arm

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

  6. The use of each upper extremity in activities of daily living

    Measured by the magnitude and ratio of arm movements over a 10-day period from wrist worn accelerometers on each arm

    Measured: Change from Post at Post 3 months (retention)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2020
  2. Study start1 Feb 2021
  3. Primary completion26 Mar 2025
  4. Study completion26 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04291573
Sponsor's protocol ID
RECHMPL19_0080
Other IDs
2019-A00506-51
Acronym
ReArm
Status last verified
Apr 2025
First submitted
3 Jan 2020
Last updated
12 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data available upon request through a data access

Publications

  • 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.

    PubMed 37106460
  • 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.

    PubMed 25212522
  • 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.

    PubMed 25261273
  • 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.

    PubMed 29156493
  • 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.

    PubMed 29311747
  • 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.

    PubMed 27372845
  • 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.

    PubMed 28279641
  • 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.

    PubMed 23727025
  • 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.

    PubMed 27445739
  • 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.

    PubMed 27089207
  • 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.

    PubMed 30428896
  • 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.

    PubMed 26433609
  • 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.

    PubMed 27899754
  • 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.

    PubMed 34702317

Questions about this trial

What is this clinical trial studying?

A study testing HD-tDCS in people with Chronic Post Stroke Individuals, run by University Hospital, Montpellier at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04291573, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.

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