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

Primary Purpose

Chronic Post Stroke Individuals

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
HD-tDCS
Sham HD-tDCS
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Post Stroke Individuals focused on measuring Stroke, HD-tDCS, Virtual Reality Therapy, Physical therapy

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Montpellier hospital LapeyronieRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

HD-tDCS and Virtual Reality Therapy

Sham stimulation and Virtual Reality Therapy

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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 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 in Activities of daily living
Measured by the Barthel Index (0-100 where higher scores mean a better outcome)
Change in Activities of daily living
Measured by the Barthel Index (0-100 where higher scores mean a better outcome)
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
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

Full Information

First Posted
January 3, 2020
Last Updated
March 4, 2023
Sponsor
University Hospital, Montpellier
Collaborators
Université Montpellier, Groupement Interrégional de Recherche Clinique et d'Innovation, IMT Mines Alès
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1. Study Identification

Unique Protocol Identification Number
NCT04291573
Brief Title
Recovering Arm Function in Chronic Post-stroke Patients Using Combined HD-tDCS and Virtual Reality Therapy
Acronym
ReArm
Official Title
Recovering Arm Function in Chronic Post-stroke Patients Using Combined HD-tDCS and Virtual Reality Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
Collaborators
Université Montpellier, Groupement Interrégional de Recherche Clinique et d'Innovation, IMT Mines Alès

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Post Stroke Individuals
Keywords
Stroke, HD-tDCS, Virtual Reality Therapy, Physical therapy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
58 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HD-tDCS and Virtual Reality Therapy
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Sham stimulation and Virtual Reality Therapy
Arm Type
Sham Comparator
Arm Description
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)
Intervention Type
Device
Intervention Name(s)
HD-tDCS
Other Intervention Name(s)
Starstim8 (Neuroelectrics, Spain)
Intervention Description
Real stimulation (2mA, 20min) with anode on C3/C4 of the lesioned hemisphere and 4 return electrodes ~4cm away
Intervention Type
Device
Intervention Name(s)
Sham HD-tDCS
Other Intervention Name(s)
Starstim8 (Neuroelectrics, Spain)
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in Functional Motor capacity of the upper extremity
Description
Arm functional capacity assessed by the Wolf Motor Function Test (WMFT) (0-75, where higher scores mean better arm functional capacity)
Time Frame
Change from Baseline at Day 21(after intervention) and 3 months after day 21
Title
Change in Functional Motor capacity of the upper extremity
Description
Arm functional capacity assessed by the Wolf Motor Function Test (WMFT) (0-75, where higher scores mean better arm functional capacity)
Time Frame
Change from Day 21 at 3 months (retention)
Title
Change in Motor deficit of the upper extremity
Description
Measured by the Fugl-Meyer Upper Extremity (FMUE) score (0-66, where higher scores mean a better recovery)
Time Frame
Change from Baseline at Day 21 (after intervention) and 3 months after day 21
Title
Change in Motor deficit of the upper extremity
Description
Measured by the Fugl-Meyer Upper Extremity (FMUE) score (0-66, where higher scores mean a better recovery)
Time Frame
Change from Day 21 at 3 months (retention)
Title
Change in Hand dexterity
Description
Measured by the Box and Block Test (BBT) score (greater number of blocks moved in 1minute means better hand dexterity)
Time Frame
Change in Baseline at Day 21 (after intervention) and 3 months after day 21
Title
Change in Hand dexterity
Description
Measured by the Box and Block Test (BBT) score (greater number of blocks moved in 1minute means better hand dexterity)
Time Frame
Change in Day21 at 3 months (retention)
Secondary Outcome Measure Information:
Title
Change in Non-use of the paretic upper extremity
Description
Measured by the Proximal Arm Non-Use (PANU) score during an arm reaching task (0-100 where higher scores mean a worse outcome)
Time Frame
Change from Baseline at Day 21 (after intervention) and 3 months after day 21
Title
Change in Non-use of the paretic upper extremity
Description
Measured by the Proximal Arm Non-Use (PANU) score during an arm reaching task (0-100 where higher scores mean a worse outcome)
Time Frame
Change from Day 21 at 3 months (retention)
Title
Change in Activities of daily living
Description
Measured by the Barthel Index (0-100 where higher scores mean a better outcome)
Time Frame
Change from Baseline at Day 21 (after intervention) and 3 months after day 21
Title
Change in Activities of daily living
Description
Measured by the Barthel Index (0-100 where higher scores mean a better outcome)
Time Frame
Change from Day 21 at 3 months (retention)
Title
The use of the paretic upper extremity in activities of daily living
Description
Measured by the magnitude and ratio of arm movements over a 10-day period from wrist worn accelerometers on each arm
Time Frame
Change from Baseline at Post (10 days after the intervention), and Post 3 months (10 days at 3 months post intervention)
Title
The use of each upper extremity in activities of daily living
Description
Measured by the magnitude and ratio of arm movements over a 10-day period from wrist worn accelerometers on each arm
Time Frame
Change from Post at Post 3 months (retention)
Other Pre-specified Outcome Measures:
Title
Change in Interhemispheric Sensorimotor cortex haemodynamics (functional near-infrared spectroscopy-fNIRS)
Description
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
Time Frame
Change from Baseline at Day 21 (after intervention)
Title
Change in Interhemispheric Sensorimotor cortex haemodynamics (functional near-infrared spectroscopy-fNIRS)
Description
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
Time Frame
Change from Day 21 at 3 months (retention)
Title
Change in Interhemispheric Sensorimotor cortex neural oscillations (Electroencephalography- EEG)
Description
Measured by the magnitude and ratio of alpha/beta frequency power in the ipsilesional and contralesional sensorimotor cortex at rest and during arm movements
Time Frame
Change from Baseline at Day 21 (after intervention)
Title
Change in Interhemispheric Sensorimotor cortex neural oscillations (Electroencephalography- EEG)
Description
Measured by the magnitude and ratio of alpha/beta frequency power in the ipsilesional and contralesional sensorimotor cortex at rest and during arm movements
Time Frame
Change from Day 21 at 3 months (retention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karima KA Bakhti, PhD
Phone
+33 4 67 33 61 11
Email
k-bakhti@chu-montpellier.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karima KA Bakhti, PhD
Organizational Affiliation
Montpellier hospital Lapeyronie
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montpellier hospital Lapeyronie
City
Montpellier
ZIP/Postal Code
34000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claire Chauveton
Phone
+33 4 67 33 09 24
Email
c-chauveton@chu-montpellier.fr

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data available upon request through a data access
Citations:
PubMed Identifier
25212522
Citation
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Results Reference
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Citation
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Citation
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Citation
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Recovering Arm Function in Chronic Post-stroke Patients Using Combined HD-tDCS and Virtual Reality Therapy

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