Virtual Reality Based TherapyNCT03144102
Combining tDCS With VR-based Motor Training in Stroke
A study testing Virtual Reality-based therapy for upper-limbs motor rehabilitation, Anodal transcranial direct-current stimulation (tDCS) and Occupational Therapy for upper-limbs motor rehabilitation in people with Virtual Reality Based Therapy and Anodal tDCS, run by Universitat Pompeu Fabra at 1 site in Spain.
Trial summary
Stroke represents one of the main causes of adult disability and will be one of the main contributors to the burden of disease in 2030. However, our healthcare systems do not have enough resources to cover the current demand let alone its future increase. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Virtual Reality Based Therapy, Anodal tDCS, Occupational Therapy
- What is being tested?
- Virtual Reality-based therapy for upper-limbs motor rehabilitation, Anodal transcranial direct-current stimulation (tDCS) and Occupational Therapy for upper-limbs motor rehabilitation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteSpain
- Study dates
- 15 May 2017to 8 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with hemiparesis secondary to first ever ischemic or hemorrhagic stroke (Medical Research Council score > 2).
- Older than 18 years old.
- Sufficient cognitive capacity to understand and follow the experimental instructions (Mini-Mental State Evaluation > 20).
Who cannot join
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
- Epilepsia and metal implants. A diagnostic EEG will be performed by the Department of Clinical Neurophysiology of the hospital to detect epileptic paroxysmal in order to include or exclude patients in the study.
- Low Cognitive capabilities that prohibits the execution of the experiment Arteriovenous malformation
- Severe associated impairment such as spasticity, communication disabilities (sensorial, mixed or global aphasia or apraxia), major pain or other neuromuscular impairments or orthopaedic devices that would interfere with the correct execution of the experiment (Modified Ashworth Scale > 3)
- History of serious mental-health problems in acute or sub acute phase
- Refusal to sign the consent form
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- Previous surgeries opening the skull.
- Active or recent substance abuse or dependence within the past year.
- Pregnancy, breastfeeding, unwillingness to practice birth control during participation in the study.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Unitat de Rehabilitació de l'Hospital Vall d'Hebron
Barcelona, 08035
Susana Rodríguez, Dr.
About this study
Official title: The Effects of Combining Transcranial Direct Current Stimulation (tDCS) With VR-based Motor Training in Hemiparetic Stroke Patients
Stroke represents one of the main causes of adult disability and will be one of the main contributors to the burden of disease in 2030. However, our healthcare systems do not have enough resources to cover the current demand let alone its future increase. There is a need to deploy new approaches that advance the current rehabilitation methods and enhance their efficiency.
One of the latest approaches used for the rehabilitation of a wide range of deficits of the nervous system is based on virtual reality (VR) applications, which combine training scenarios with dedicated interface devices. On the other hand, recent studies have shown the potential of transcranial direct current stimulation (tDCS) to restore motor function in hemiparetic stroke patients. It must be emphasized, however, that so far little work exists on the quantitative assessment of the clinical impact of VR based approaches in combination with tDCS protocols. We hypothesize that the combination of VR-based motor rehabilitation protocols with concurrent anodal tDCS can boost functional recovery, and may achieve superior effects when compared to 3 alternative treatments: 1) VR without tDCS, 2) occupational therapy with tDCS, and 3) occupational therapy without tDCS.
The findings derived from this study will contribute to establish a novel and superior neurorehabilitation paradigm that can accelerates the recovery of hemiparetic stroke patients. Besides the clinical impact, such achievement could have relevant socioeconomic impact.
- Being tested
- Virtual Reality-based therapy for upper-limbs motor rehabilitation, Anodal transcranial direct-current stimulation (tDCS), Occupational Therapy for upper-limbs motor rehabilitation, Sham transcranial direct-current stimulation (tDCS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality-based therapy for upper-limbs motor rehabilitationBehavioural
During each session, the subject will perform 4 VR-based exercises that involve reaching, grasping, and intercepting virtual objects. The training will last a total of 30 min per session.
Anodal transcranial direct-current stimulation (tDCS)Device
Concurrent anodal tDCS on sensorimotor cortex on the ipsilesional hemisphere.
Occupational Therapy for upper-limbs motor rehabilitationBehavioural
During each session, the subject will perform 4 occupational therapy exercises that involve reaching, grasping, and intercepting objects. The training will last a total of 30 min per session.
Sham transcranial direct-current stimulation (tDCS)Device
Concurrent sham tDCS on sensorimotor cortex on the ipsilesional hemisphere.
| Study group | Role | What they receive |
|---|---|---|
| VR-based motor rehabilitation with tDCS | Experimental | Not described Receives: Behavioral: Virtual Reality-based therapy for upper-limbs motor rehabilitation; Device: Anodal transcranial direct-current stimulation (tDCS) |
| Occupational Therapy with tDCS | Active comparator | Not described Receives: Device: Anodal transcranial direct-current stimulation (tDCS); Behavioral: Occupational Therapy for upper-limbs motor rehabilitation |
| VR-based motor rehabilitation with sham tDCS | Sham comparator | Not described Receives: Behavioral: Virtual Reality-based therapy for upper-limbs motor rehabilitation; Device: Sham transcranial direct-current stimulation (tDCS) |
| Occupational Therapy with sham tDCS | Sham comparator | Not described Receives: Behavioral: Occupational Therapy for upper-limbs motor rehabilitation; Device: Sham transcranial direct-current stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of arm/hand function as captured by the upper extremity Fugl-Meyer assessment scale
Measured: At baseline, at 2-weeks (after intervention), and at 8-weeks (follow-up)
Secondary outcomes (5)
Change of Independence as captured by Barthel scale
Measured: At baseline, at 2-weeks (after intervention), and at 8-weeks (follow-up)
Change of motor function in ADLs as captured by Chedoke Arm and Hand Activity Inventory (CAHAI) scale
Measured: At baseline, at 2-weeks (after intervention), and at 8-weeks (follow-up)
Change of interhemispheric balance as captured by EEG recordings
Measured: At baseline, at 2-weeks (after intervention), and at 8-weeks (follow-up)
Change of spasticity in proximal and distal muscles as captured by Ashworth scale
Measured: At baseline, at 2-weeks (after intervention), and at 8-weeks (follow-up)
Change of spatial hemineglect as captured by the Star cancellation test
Measured: At baseline, at 2-weeks (after intervention), and at 8-weeks (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2017
- Study start15 May 2017
- Primary completion8 Dec 2020 (estimated)
- Study completion8 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Virtual Reality Based TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitat Pompeu Fabra
- Sponsor type
- University, hospital or other
- Collaborators
- Neuroelectrics Corporation
- Responsible party
- Principal investigator, Paul Verschure, Universitat Pompeu Fabra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03144102
- Sponsor's protocol ID
- tDCSRGS
- Status last verified
- Aug 2020
- First submitted
- 4 May 2017
- Last updated
- 10 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Combining Transcranial Direct Current Stimulation (tDCS) With VR-based Motor Training in Hemiparetic Stroke Patients
- ClinicalTrials.gov ID
- NCT03144102
- Acronym / sponsor ID
- tDCSRGS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Universitat Pompeu FabraUniversity, hospital or other
- Collaborators
- Neuroelectrics Corporation
- Study start
- 15 May 2017 (actual)
- Primary completion
- 8 Dec 2020 (estimated)
- Study completion
- 8 Jun 2021 (estimated)
- First posted
- 8 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Stroke represents one of the main causes of adult disability and will be one of the main contributors to the burden of disease in 2030. However, our healthcare systems do not have enough resources to cover the current demand let alone its future increase. There is a need to deploy new approaches that advance the current rehabilitation methods and enhance their efficiency.
One of the latest approaches used for the rehabilitation of a wide range of deficits of the nervous system is based on virtual reality (VR) applications, which combine training scenarios with dedicated interface devices. On the other hand, recent studies have shown the potential of transcranial direct current stimulation (tDCS) to restore motor function in hemiparetic stroke patients. It must be emphasized, however, that so far little work exists on the quantitative assessment of the clinical impact of VR based approaches in combination with tDCS protocols. We hypothesize that the combination of VR-based motor rehabilitation protocols with concurrent anodal tDCS can boost functional recovery, and may achieve superior effects when compared to 3 alternative treatments: 1) VR without tDCS, 2) occupational therapy with tDCS, and 3) occupational therapy without tDCS.
The findings derived from this study will contribute to establish a novel and superior neurorehabilitation paradigm that can accelerates the recovery of hemiparetic stroke patients. Besides the clinical impact, such achievement could have relevant socioeconomic impact.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| VR-based motor rehabilitation with tDCS | Experimental | Behavioral: Virtual Reality-based therapy for upper-limbs motor rehabilitation, Device: Anodal transcranial direct-current stimulation (tDCS) |
| Occupational Therapy with tDCS | Active comparator | Device: Anodal transcranial direct-current stimulation (tDCS), Behavioral: Occupational Therapy for upper-limbs motor rehabilitation |
| VR-based motor rehabilitation with sham tDCS | Sham comparator | Behavioral: Virtual Reality-based therapy for upper-limbs motor rehabilitation, Device: Sham transcranial direct-current stimulation (tDCS) |
| Occupational Therapy with sham tDCS | Sham comparator | Behavioral: Occupational Therapy for upper-limbs motor rehabilitation, Device: Sham transcranial direct-current stimulation (tDCS) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with hemiparesis secondary to first ever ischemic or hemorrhagic stroke (Medical Research Council score > 2).
- Older than 18 years old.
- Sufficient cognitive capacity to understand and follow the experimental instructions (Mini-Mental State Evaluation > 20).
Key exclusion criteria (9 listed)
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
- Epilepsia and metal implants. A diagnostic EEG will be performed by the Department of Clinical Neurophysiology of the hospital to detect epileptic paroxysmal in order to include or exclude patients in the study.
- Low Cognitive capabilities that prohibits the execution of the experiment Arteriovenous malformation
- Severe associated impairment such as spasticity, communication disabilities (sensorial, mixed or global aphasia or apraxia), major pain or other neuromuscular impairments or orthopaedic devices that would interfere with the correct execution of the experiment (Modified Ashworth Scale > 3)
- History of serious mental-health problems in acute or sub acute phase
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality-based therapy for upper-limbs motor rehabilitationDuring each session, the subject will perform 4 VR-based exercises that involve reaching, grasping, and intercepting virtual objects. The training will last a total of 30 min per session. | Behavioural | VR-based motor rehabilitation with sham tDCS, VR-based motor rehabilitation with tDCS |
| Anodal transcranial direct-current stimulation (tDCS)Concurrent anodal tDCS on sensorimotor cortex on the ipsilesional hemisphere. | Device | Occupational Therapy with tDCS, VR-based motor rehabilitation with tDCS |
| Occupational Therapy for upper-limbs motor rehabilitationDuring each session, the subject will perform 4 occupational therapy exercises that involve reaching, grasping, and intercepting objects. The training will last a total of 30 min per session. | Behavioural | Occupational Therapy with sham tDCS, Occupational Therapy with tDCS |
| Sham transcranial direct-current stimulation (tDCS)Concurrent sham tDCS on sensorimotor cortex on the ipsilesional hemisphere. | Device | Occupational Therapy with sham tDCS, VR-based motor rehabilitation with sham tDCS |
Primary outcome
Change of arm/hand function as captured by the upper extremity Fugl-Meyer assessment scale
Time frame: At baseline, at 2-weeks (after intervention), and at 8-weeks (follow-up)
5 secondary outcomes
Change of Independence as captured by Barthel scale
Time frame: At baseline, at 2-weeks (after intervention), and at 8-weeks (follow-up)
Change of motor function in ADLs as captured by Chedoke Arm and Hand Activity Inventory (CAHAI) scale
Time frame: At baseline, at 2-weeks (after intervention), and at 8-weeks (follow-up)
Change of interhemispheric balance as captured by EEG recordings
Time frame: At baseline, at 2-weeks (after intervention), and at 8-weeks (follow-up)
Change of spasticity in proximal and distal muscles as captured by Ashworth scale
Time frame: At baseline, at 2-weeks (after intervention), and at 8-weeks (follow-up)
Change of spatial hemineglect as captured by the Star cancellation test
Time frame: At baseline, at 2-weeks (after intervention), and at 8-weeks (follow-up)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality-based therapy for upper-limbs motor rehabilitation, Anodal transcranial direct-current stimulation (tDCS) and Occupational Therapy for upper-limbs motor rehabilitation in people with Virtual Reality Based Therapy and Anodal tDCS, run by Universitat Pompeu Fabra at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paul Verschure, Prof. (0034935422202, paul.verschure@upf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of arm/hand function as captured by the upper extremity Fugl-Meyer assessment scale (time frame: At baseline, at 2-weeks (after intervention), and at 8-weeks (follow-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2020.