Clinical trial NCT04291573: Recovering Arm Function in Chronic Post-stroke Patients Using Combined HD-tDCS and Virtual Reality Therapy
Official title: Recovering Arm Function in Chronic Post-stroke Patients Using Combined HD-tDCS and Virtual Reality Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Post Stroke Individuals
Keywords: Stroke
HD-tDCS
Virtual Reality Therapy
Physical therapy
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Université Montpellier
name: Groupement Interrégional de Recherche Clinique et d'Innovation
name: IMT Mines Alès
First posted: 2020-03-02
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Change in Functional Motor capacity of the upper extremity
timeFrame: Change from Baseline at Day 21(after intervention) and 3 months after day 21
measure: Change in Functional Motor capacity of the upper extremity
timeFrame: Change from Day 21 at 3 months (retention)
measure: Change in Motor deficit of the upper extremity
timeFrame: Change from Baseline at Day 21 (after intervention) and 3 months after day 21
measure: Change in Motor deficit of the upper extremity
timeFrame: Change from Day 21 at 3 months (retention)
measure: Change in Hand dexterity
timeFrame: Change in Baseline at Day 21 (after intervention) and 3 months after day 21
measure: Change in Hand dexterity
timeFrame: Change in Day21 at 3 months (retention)
Secondary outcomes:
measure: Change in Non-use of the paretic upper extremity
timeFrame: Change from Baseline at Day 21 (after intervention) and 3 months after day 21
measure: Change in Non-use of the paretic upper extremity
timeFrame: Change from Day 21 at 3 months (retention)
measure: Change in Activities of daily living
timeFrame: Change from Baseline at Day 21 (after intervention) and 3 months after day 21
measure: Change in Activities of daily living
timeFrame: Change from Day 21 at 3 months (retention)
measure: The use of the paretic upper extremity in activities of daily living
timeFrame: Change from Baseline at Post (10 days after the intervention), and Post 3 months (10 days at 3 months post intervention)
measure: The use of each upper extremity in activities of daily living
timeFrame: Change from Post at Post 3 months (retention)
Other outcomes:
measure: Change in Interhemispheric Sensorimotor cortex haemodynamics (functional near-infrared spectroscopy-fNIRS)
timeFrame: Change from Baseline at Day 21 (after intervention)
measure: Change in Interhemispheric Sensorimotor cortex haemodynamics (functional near-infrared spectroscopy-fNIRS)
timeFrame: Change from Day 21 at 3 months (retention)
measure: Change in Interhemispheric Sensorimotor cortex neural oscillations (Electroencephalography- EEG)
timeFrame: Change from Baseline at Day 21 (after intervention)
measure: Change in Interhemispheric Sensorimotor cortex neural oscillations (Electroencephalography- EEG)
timeFrame: Change from Day 21 at 3 months (retention)
Locations:
city: Montpellier
country: France
facility: Montpellier hospital Lapeyronie
Study officials:
affiliation: Montpellier hospital Lapeyronie
name: Karima KA Bakhti, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.