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

Chronic Post Stroke Individuals Clinical Trial

— ReArm  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04291573
• Other study ID #: UF 7780
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: May 1, 2027

Study information

• Verified date: January 2024
• Source: University Hospital, Montpellier
• Contact: Karima KA Bakhti, PhD
• Phone: +33 4 67 33 61 11
• Email: k-bakhti[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 58
• Est. completion date: May 1, 2027
• Est. primary completion date: May 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Post Stroke Individuals
• Stroke

Intervention

Device:
• HD-tDCS
Real stimulation (2mA, 20min) with anode on C3/C4 of the lesioned hemisphere and 4 return electrodes ~4cm away
• Sham HD-tDCS
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

Locations

Country	Name	City	State
France	Montpellier hospital Lapeyronie	Montpellier

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Montpellier	Groupement Interrégional de Recherche Clinique et d'Innovation, IMT Mines Alès, Université Montpellier

Country where clinical trial is conducted

France, 

References & Publications (12)

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/scit — View 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. — View 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, Ni — View 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 — View 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.2 — View 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 — View 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. — View 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 — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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)
Other	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)
Other	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)
Primary	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
Primary	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)
Primary	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
Primary	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)
Primary	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
Primary	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	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
Secondary	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 Day 21 at 3 months (retention)
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)