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

Not Applicable

Completed

• Conditions: Chronic Post Stroke Individuals
• Interventions: Device: Sham HD-tDCS; Device: HD-tDCS

• Registration Number: NCT04291573
• Lead Sponsor: University Hospital, Montpellier

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

Study Timeline

• Study First Submitted: 2020-01-03
• Study First Submitted QC: 2020-02-27
• Study First Posted: 2020-03-02
• Study Start: 2021-02-01
• Primary Completion: 2025-03-26
• Study Completion: 2025-03-26
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-10
• Last Update Posted: 2025-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham stimulation and Virtual Reality Therapy	Sham HD-tDCS	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)
HD-tDCS and Virtual Reality Therapy	HD-tDCS	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)

Primary Outcome Measures

Name	Time	Method
Change in Functional Motor capacity of the upper extremity	Change from Day 21 at 3 months (retention)	Arm functional capacity assessed by the Wolf Motor Function Test (WMFT) (0-75, where higher scores mean better arm functional capacity)
Change in Hand dexterity	Change in Day21 at 3 months (retention)	Measured by the Box and Block Test (BBT) score (greater number of blocks moved in 1minute means better hand dexterity)
Change in Motor deficit of the upper extremity	Change from Day 21 at 3 months (retention)	Measured by the Fugl-Meyer Upper Extremity (FMUE) score (0-66, where higher scores mean a better recovery)

Secondary Outcome Measures

Name	Time	Method
Change in Non-use of the paretic upper extremity	Change from Day 21 at 3 months (retention)	Measured by the Proximal Arm Non-Use (PANU) score during an arm reaching task (0-100 where higher scores mean a worse outcome)
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)	Measured by the magnitude and ratio of arm movements over a 10-day period from wrist worn accelerometers on each arm
The use of each upper extremity in activities of daily living	Change from Post at Post 3 months (retention)	Measured by the magnitude and ratio of arm movements over a 10-day period from wrist worn accelerometers on each arm
Change in Activities of daily living	Change from Day 21 at 3 months (retention)	Measured by the Barthel Index (0-100 where higher scores mean a better outcome)

Trial Locations

Locations (1)

Montpellier hospital Lapeyronie; 🇫🇷 Montpellier, France