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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-A00506-51 | Registry Identifier | ID-RCB |
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| Name | Class |
|---|---|
| Université Montpellier | OTHER |
| Groupement Interrégional de Recherche Clinique et d'Innovation | OTHER |
| IMT Mines Alès | UNKNOWN |
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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.
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:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
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| 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) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HD-tDCS | Device | Real stimulation (2mA, 20min) with anode on C3/C4 of the lesioned hemisphere and 4 return electrodes ~4cm away |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Change from Baseline at Day 21 (after intervention) and 3 months after day 21 |
| Change in Non-use of the paretic upper extremity |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Interhemispheric Sensorimotor cortex haemodynamics (functional near-infrared spectroscopy-fNIRS) | 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) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karima KA Bakhti, PhD | Montpellier hospital Lapeyronie | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montpellier hospital Lapeyronie | Montpellier | 34000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37106460 | Result | 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. | |
| 25212522 | Result | 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. |
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Data available upon request through a data access
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| 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 |
|
|
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 | 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 | 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 | 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 | 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) |
| Change in Interhemispheric Sensorimotor cortex haemodynamics (functional near-infrared spectroscopy-fNIRS) |
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) | 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) | 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) |
| 25261273 | Result | 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. |
| 29156493 | Result | 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. |
| 29311747 | Result | 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. |
| 27372845 | Result | 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. |
| 28279641 | Result | 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. |
| 23727025 | Result | 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. |
| 27445739 | Result | 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. |
| 27089207 | Result | 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. |
| 30428896 | Result | 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. |
| 26433609 | Result | 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. |
| 27899754 | Result | 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. |
| 34702317 | 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. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |