Stroke is a disabling medical condition annually affecting up to 15 million people worldwide. It leads to upper-limb impairments encompassing motor and sensory deficits together with cognitive self-body and space misrepresentation, overall limiting the functional independence of 70% of stroke survivors. On the motor side, stroke could account for hemiparesis (weakness or paralysis affecting the side contralateral to the brain lesion), muscle weakness, spasticity, loss of coordination, and others. On the sensory side, especially in the first stages after the stroke occurs, stroke could account for sensory loss, with the patient not being able to perceive what he's touching with the impaired arm.On a cognitive level, it has been shown that chronic stroke patients have distorted body representation and space representation. They perceive their impaired arm as shorter and the impaired hand as larger.

Despite initial evidence of the crucial role of sensory-motor integration toward a restored body representation to promote effective rehabilitation, conventional approaches suffer from the bias of prioritizing motor recovery, while disregarding stroke-induced sensory and body representation deficits.

In this view, the creation of a virtual reality (VR) scenario in which the person is fully immersed, could potentially play a significant role in improving stroke patients' rehabilitation.

Taking this into consideration, this project aims to assess whether a multimodal platform combining VR with TENS inducing full-body illusion toward a virtual avatar could positively impact motor performances, sensory assessments, and self-body and space representation of stroke patients.

More into detail, the intervention will consist of the patient performing some task-oriented movement within the virtual reality and congruently tactile receiving feedback through transcutaneous electrical nerve stimulation. The subject will receive clear instruction within the virtual reality scenario to perform specific actions toward a final goal. These actions will be designed to make the subject repeat some crucial movements in their rehabilitation process. Depending on the motor impairment of the patient, the investigators will adapt the characteristics and the difficulty of the task accordingly.

Conditions: Stroke
Being tested: VR+TENS, Conventional rehabilitation
Keywords: Virtual Reality, TENS, Stoke, Task-oriented rehabilitation, Multimodal intervention
Medical subject headings: Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VR+TENSOther
During the invention, patients will be in VR scenarios and play task-oriented games, interacting with elements that appear in the virtual world, to improve mobility and functional independence of the upper limbs.
The task-oriented games will target different components depending on the disability of the patient.
Conventional rehabilitationOther
Patients will perform conventional upper-limb stroke rehabilitation. The movement performed will be comparable with the movement performed in the VR+TENS group

Study groups in NCT06400823
Study group	Role	What they receive
VR+TENS	Experimental	Patients will undergo goal-oriented movements for upper-limb rehabilitation in a VR scenario. While performing the movement, patients will receive synchronous electrical stimulation targeting the medial nerve. The provided sensation will stimulate the interaction with elements in the virtual world. The intervention phase will last 3 weeks. Patients will undergo a minimum of three sessions per week (of around 60'). During each of these sessions, the first 10' will be employed for the calibration of the Transcutaneous Electrical Nerve Stimulation (TENS). In the remaining part of the session, subjects will perform some of the VR-based task-oriented games targeting different components. Receives: Other: VR+TENS
Conventional rehabilitation	Active comparator	Patients in the control group will perform physical conventional rehabilitation provided by the rehabilitation clinic. The total amount of therapy will be the same as that of the VR+TENS group. The exercises will target the same components of the VR+TENS arm. Receives: Other: Conventional rehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

Changes in sensorimotor impairments
To assess the sensorimotor impairment in individuals who have had a stroke the investigators will use Fugl-Meyer for upper extremity (FMUE). FMUE assesses reflex activity, movement control, muscle strength, and sensory performances. It comprises items scored on a scale of 0 to 2, where 0 = cannot perform, 1 = performs partially and 2 = performs fully.
Measured: day 0 (before the first rehabilitation session, T0); 1.5 week (after six rehabilitation sessions, T1); 3 weeks (one day after the last rehabilitation session, T2); 5 weeks (2 weeks after the last rehabilitation session,T3)
Changes in functional performances
To assess functional performance of the upper extremity through observational means the investigators will use the Action Research Arm Test (ARAT). The ARAT is a 19-item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). The total score goes from 0 to 57. Performance on each item is rated on a 4-point ordinal scale ranging from: 3) Performs test normally 2) Completes test, but takes abnormally long or has great difficulty 1) Performs test partially 0) Can perform no part of test.
Measured: day 0 (before the first rehabilitation session, T0); 1.5 week (after six rehabilitation sessions, T1); 3 weeks (one day after the last rehabilitation session, T2); 5 weeks (2 weeks after the last rehabilitation session,T3)
Changes in body-representation metrics
To measure the body representation of the subjects the investigators will use body-landmark metrics. In VR, the subject is asked to locate the position of specific body landmarks (e.g. elbow, inner wrist, outer wrist, index, ring) while a black panel is on top of his/her arm. The investigators will then compare the real and perceived dimensions of patients' arms and hands
Measured: day 0 (before the first rehabilitation session, T0); 1.5 week (after six rehabilitation sessions, T1); 3 weeks (one day after the last rehabilitation session, T2); 5 weeks (2 weeks after the last rehabilitation session,T3)

Secondary outcomes (11)

Changes in degree of assistance required by an individual
To assess the degree of assistance required by an individual on ten mobility and self-care the investigators will use the Barthel Index. The score goes from 0 to 100. It consists of an ordinal scale which measures a person's ability to complete activities of daily living (ADL).
Measured: day 0 (before the first rehabilitation session, T0); 1.5 week (after six rehabilitation sessions, T1); 3 weeks (one day after the last rehabilitation session, T2); 5 weeks (2 weeks after the last rehabilitation session,T3)
Changes in peripersonal space
To measure the peri-personal space of stroke patients (the space in which multisensory integration is enhanced). Test Performance: In VR, the subject is sitting on a table and sees balls approaching him. He/she's asked to press a controller whenever he/she feels electrical stimulation.
Measured: day 0 (before the first rehabilitation session, T0); 1.5 week (after six rehabilitation sessions, T1); 3 weeks (one day after the last rehabilitation session, T2); 5 weeks (2 weeks after the last rehabilitation session,T3)
Changes of spasticity indexes for shoulder, elbow and wrist
The investigators will use Ashworth Scale to test resistance to passive movement about a joint with varying degrees of velocity. This test is performed by extending the patients limb first from a position of maximal possible flexion to maximal possible extension (the point at which the first soft resistance is met).
Measured: day 0 (before the first rehabilitation session, T0); 1.5 week (after six rehabilitation sessions, T1); 3 weeks (one day after the last rehabilitation session, T2); 5 weeks (2 weeks after the last rehabilitation session,T3)
Changes in pain perception
To quantify the experience of pain. This will be evaluated with Visual Analogue Scale. The score goes from 0 to 10.
Measured: Every day, from day 1 to day 14; 5 weeks (2 weeks after the last rehabilitation session,T3)
Changes in neuropathic pain perception
To quantify the experience of pain. This will be evaluated with Neuropathic Pain Symptom Inventory (The score goes from 0 to 100)
Measured: day 0 (before the first rehabilitation session, T0); 1.5 week (after six rehabilitation sessions, T1); 3 weeks (one day after the last rehabilitation session, T2); 5 weeks (2 weeks after the last rehabilitation session,T3)
Treatment Satisfaction Measure
The subject marks on the treatment satisfaction on a Likert-scale.
Measured: 3 weeks (one day after the last rehabilitation session, T2)
Changes in tactile acuity
To measure the tactile acuity of patients we will use the Two-Point discrimination test. While blindfolded, the patient is repetitively touched with either one or two pins (fixed distance) and he asked to tell how many pins he/she feels.
Measured: day 0 (before the first rehabilitation session, T0); 1.5 week (after six rehabilitation sessions, T1); 3 weeks (one day after the last rehabilitation session, T2); 5 weeks (2 weeks after the last rehabilitation session,T3)
Changes in upper-limb mobility (velocity)
To assess changes in velocity the investigators will measure kinematic velocity of the patients while performing rehabilitation tasks.
Measured: Every day, from day 1 to day 14
Changes in upper-limb mobility (smoothness)
To assess changes in smoothness the investigators will measure kinematic smoothness of the patients while performing rehabilitation tasks.
Measured: Every day, from day 1 to day 14
Changes in upper-limb mobility (efficiency)
To assess changes in efficiency the investigators will measure the amount and rate of task-oriented movements of the patients.
Measured: Every day, from day 1 to day 14
Changes in upper-limb mobility (precision)
To assess changes in precision the investigators will measure the spatial precision (error with respect to a predefined correct movement) during the task-oriented movements of the patient.
Measured: Every day, from day 1 to day 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Apr 20241 Jun 2026

First posted6 May 2024
Study start22 Apr 2024
Primary completion1 Jun 2026 (estimated)
Study completion1 Jun 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (9)Papers the sponsor has linked to this study.
Other trials for StrokeStudies 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: Parallel groups
Model description: The study has a parallel design, with two different groups. 1. TENS+VR group 2. Conventional therapy group
Masking: Single blind
Who is masked: Participant
Enrolment: 40 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06400823
Sponsor's protocol ID: VRTENSSTROKE
Status last verified: May 2024
First submitted: 19 Apr 2024
Last updated: 9 Dec 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Edwards LL, King EM, Buetefisch CM, Borich MR. Putting the "Sensory" Into Sensorimotor Control: The Role of Sensorimotor Integration in Goal-Directed Hand Movements After Stroke. Front Integr Neurosci. 2019 May 22;13:16. doi: 10.3389/fnint.2019.00016. eCollection 2019.
PubMed 31191265
Bassolino M, Franza M, Guanziroli E, Sorrentino G, Canzoneri E, Colombo M, Crema A, Bertoni T, Mastria G, Vissani M, Sokolov AA, Micera S, Molteni F, Blanke O, Serino A. Body and peripersonal space representations in chronic stroke patients with upper limb motor deficits. Brain Commun. 2022 Aug 5;4(4):fcac179. doi: 10.1093/braincomms/fcac179. eCollection 2022.
PubMed 35950092
Doyle S, Bennett S, Fasoli SE, McKenna KT. Interventions for sensory impairment in the upper limb after stroke. Cochrane Database Syst Rev. 2010 Jun 16;2010(6):CD006331. doi: 10.1002/14651858.CD006331.pub2.
PubMed 20556766
Ingram LA, Butler AA, Brodie MA, Lord SR, Gandevia SC. Quantifying upper limb motor impairment in chronic stroke: a physiological profiling approach. J Appl Physiol (1985). 2021 Sep 1;131(3):949-965. doi: 10.1152/japplphysiol.00078.2021. Epub 2021 Jul 15.
PubMed 34264125
Odermatt IA, Buetler KA, Wenk N, Ozen O, Penalver-Andres J, Nef T, Mast FW, Marchal-Crespo L. Congruency of Information Rather Than Body Ownership Enhances Motor Performance in Highly Embodied Virtual Reality. Front Neurosci. 2021 Jul 2;15:678909. doi: 10.3389/fnins.2021.678909. eCollection 2021.
PubMed 34295219
Gladstone DJ, Danells CJ, Black SE. The fugl-meyer assessment of motor recovery after stroke: a critical review of its measurement properties. Neurorehabil Neural Repair. 2002 Sep;16(3):232-40. doi: 10.1177/154596802401105171.
PubMed 12234086
Hsieh CL, Hsueh IP, Chiang FM, Lin PH. Inter-rater reliability and validity of the action research arm test in stroke patients. Age Ageing. 1998 Mar;27(2):107-13. doi: 10.1093/ageing/27.2.107.
PubMed 16296669
Dworkin RH, Turk DC, Wyrwich KW, Beaton D, Cleeland CS, Farrar JT, Haythornthwaite JA, Jensen MP, Kerns RD, Ader DN, Brandenburg N, Burke LB, Cella D, Chandler J, Cowan P, Dimitrova R, Dionne R, Hertz S, Jadad AR, Katz NP, Kehlet H, Kramer LD, Manning DC, McCormick C, McDermott MP, McQuay HJ, Patel S, Porter L, Quessy S, Rappaport BA, Rauschkolb C, Revicki DA, Rothman M, Schmader KE, Stacey BR, Stauffer JW, von Stein T, White RE, Witter J, Zavisic S. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J Pain. 2008 Feb;9(2):105-21. doi: 10.1016/j.jpain.2007.09.005. Epub 2007 Dec 11.
PubMed 18055266
Aurucci GV, Djordjevic O, Cimolato A, Secerovic N, Dimkic Tomic T, Ardura Carnicero MD, Yao H, Konstantinovic L, Raspopovic S. Immersive virtual reality with synchronous neurostimulation for upper-limb recovery after stroke: a randomized feasibility trial. Nat Med. 2026 Aug;32(8):2790-2802. doi: 10.1038/s41591-026-04486-4. Epub 2026 Jun 26.
PubMed 42362865

Want to know more?

Natalija Secerovic, PhD

+381631268862

natalija.katic@pupin.rs

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multimodal Platform Combining VR and TENS for Stroke Rehabilitation
ClinicalTrials.gov ID: NCT06400823
Acronym / sponsor ID: VRTENSSTROKE
Conditions: Stroke
Keywords: Virtual Reality, TENS, Stoke, Task-oriented rehabilitation, Multimodal intervention
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 40 participants (estimated)
Lead sponsor: Institute Mihajlo PupinUniversity, hospital or other
Collaborators: ETH Zurich (Switzerland)
Study start: 22 Apr 2024 (actual)
Primary completion: 1 Jun 2026 (estimated)
Study completion: 1 Jun 2026 (estimated)
First posted: 6 May 2024 (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.

In this view, the creation of a virtual reality (VR) scenario in which the person is fully immersed, could potentially play a significant role in improving stroke patients' rehabilitation.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
Model description: The study has a parallel design, with two different groups. 1. TENS+VR group 2. Conventional therapy group

Arm	Type	Receives
VR+TENS	Experimental	Other: VR+TENSPatients will undergo goal-oriented movements for upper-limb rehabilitation in a VR scenario. While performing the movement, patients will receive synchronous electrical stimulation targeting the medial nerve. The provided sensation will stimulate the interaction with elements in the virtual world. The intervention phase will last 3 weeks. Patients will undergo a minimum of three sessions per week (of around 60'). During each of these sessions, the first 10' will be employed for the calibration of the Transcutaneous Electrical Nerve Stimulation (TENS). In the remaining part of the session, subjects will perform some of the VR-based task-oriented games targeting different components.
Conventional rehabilitation	Active comparator	Other: Conventional rehabilitationPatients in the control group will perform physical conventional rehabilitation provided by the rehabilitation clinic. The total amount of therapy will be the same as that of the VR+TENS group. The exercises will target the same components of the VR+TENS arm.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Ischemic or haemorrhagic stroke patient
At least 3 months after the stroke incident
10 <= FMUE <= 60 (motor function)

Key exclusion criteria (5 listed)

Prior neurological or psychiatric disorders
Severe cognitive impairment (MoCA score <10)
Epilepsy
Pacemakers or other electronic implants
Unable to give an informed consent form

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
VR+TENSDuring the invention, patients will be in VR scenarios and play task-oriented games, interacting with elements that appear in the virtual world, to improve mobility and functional independence of the upper limbs. The task-oriented games will target different components depending on the disability of the patient.	Other	VR+TENS
Conventional rehabilitationPatients will perform conventional upper-limb stroke rehabilitation. The movement performed will be comparable with the movement performed in the VR+TENS group	Other	Conventional rehabilitation

Primary outcome

Changes in sensorimotor impairments
Time frame: day 0 (before the first rehabilitation session, T0); 1.5 week (after six rehabilitation sessions, T1); 3 weeks (one day after the last rehabilitation session, T2); 5 weeks (2 weeks after the last rehabilitation session,T3)
To assess the sensorimotor impairment in individuals who have had a stroke the investigators will use Fugl-Meyer for upper extremity (FMUE). FMUE assesses reflex activity, movement control, muscle strength, and sensory performances. It comprises items scored on a scale of 0 to 2, where 0 = cannot perform, 1 = performs partially and 2 = performs fully.
Changes in functional performances
Time frame: day 0 (before the first rehabilitation session, T0); 1.5 week (after six rehabilitation sessions, T1); 3 weeks (one day after the last rehabilitation session, T2); 5 weeks (2 weeks after the last rehabilitation session,T3)
To assess functional performance of the upper extremity through observational means the investigators will use the Action Research Arm Test (ARAT). The ARAT is a 19-item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). The total score goes from 0 to 57. Performance on each item is rated on a 4-point ordinal scale ranging from: 3) Performs test normally 2) Completes test, but takes abnormally long or has great difficulty 1) Performs test partially 0) Can perform no part of test.
Changes in body-representation metrics
Time frame: day 0 (before the first rehabilitation session, T0); 1.5 week (after six rehabilitation sessions, T1); 3 weeks (one day after the last rehabilitation session, T2); 5 weeks (2 weeks after the last rehabilitation session,T3)
To measure the body representation of the subjects the investigators will use body-landmark metrics. In VR, the subject is asked to locate the position of specific body landmarks (e.g. elbow, inner wrist, outer wrist, index, ring) while a black panel is on top of his/her arm. The investigators will then compare the real and perceived dimensions of patients' arms and hands

11 secondary outcomes

Changes in degree of assistance required by an individual
Time frame: day 0 (before the first rehabilitation session, T0); 1.5 week (after six rehabilitation sessions, T1); 3 weeks (one day after the last rehabilitation session, T2); 5 weeks (2 weeks after the last rehabilitation session,T3)
Changes in peripersonal space
Time frame: day 0 (before the first rehabilitation session, T0); 1.5 week (after six rehabilitation sessions, T1); 3 weeks (one day after the last rehabilitation session, T2); 5 weeks (2 weeks after the last rehabilitation session,T3)
Changes of spasticity indexes for shoulder, elbow and wrist
Time frame: day 0 (before the first rehabilitation session, T0); 1.5 week (after six rehabilitation sessions, T1); 3 weeks (one day after the last rehabilitation session, T2); 5 weeks (2 weeks after the last rehabilitation session,T3)
Changes in pain perception
Time frame: Every day, from day 1 to day 14; 5 weeks (2 weeks after the last rehabilitation session,T3)
Changes in neuropathic pain perception
Time frame: day 0 (before the first rehabilitation session, T0); 1.5 week (after six rehabilitation sessions, T1); 3 weeks (one day after the last rehabilitation session, T2); 5 weeks (2 weeks after the last rehabilitation session,T3)
Treatment Satisfaction Measure
Time frame: 3 weeks (one day after the last rehabilitation session, T2)
Changes in tactile acuity
Time frame: day 0 (before the first rehabilitation session, T0); 1.5 week (after six rehabilitation sessions, T1); 3 weeks (one day after the last rehabilitation session, T2); 5 weeks (2 weeks after the last rehabilitation session,T3)
Changes in upper-limb mobility (velocity)
Time frame: Every day, from day 1 to day 14
Changes in upper-limb mobility (smoothness)
Time frame: Every day, from day 1 to day 14
Changes in upper-limb mobility (efficiency)
Time frame: Every day, from day 1 to day 14
Changes in upper-limb mobility (precision)
Time frame: Every day, from day 1 to day 14

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
Background: PubMed 31191265Edwards LL, King EM, Buetefisch CM, Borich MR. Putting the "Sensory" Into Sensorimotor Control: The Role of Sensorimotor Integration in Goal-Directed Hand Movements After Stroke. Front Integr Neurosci. 2019 May 22;13:16. doi: 10.3389/fnint.2019.00016. eCollection 2019.
Background: PubMed 35950092Bassolino M, Franza M, Guanziroli E, Sorrentino G, Canzoneri E, Colombo M, Crema A, Bertoni T, Mastria G, Vissani M, Sokolov AA, Micera S, Molteni F, Blanke O, Serino A. Body and peripersonal space representations in chronic stroke patients with upper limb motor deficits. Brain Commun. 2022 Aug 5;4(4):fcac179. doi: 10.1093/braincomms/fcac179. eCollection 2022.
Background: PubMed 20556766Doyle S, Bennett S, Fasoli SE, McKenna KT. Interventions for sensory impairment in the upper limb after stroke. Cochrane Database Syst Rev. 2010 Jun 16;2010(6):CD006331. doi: 10.1002/14651858.CD006331.pub2.
Background: PubMed 34264125Ingram LA, Butler AA, Brodie MA, Lord SR, Gandevia SC. Quantifying upper limb motor impairment in chronic stroke: a physiological profiling approach. J Appl Physiol (1985). 2021 Sep 1;131(3):949-965. doi: 10.1152/japplphysiol.00078.2021. Epub 2021 Jul 15.
Background: PubMed 34295219Odermatt IA, Buetler KA, Wenk N, Ozen O, Penalver-Andres J, Nef T, Mast FW, Marchal-Crespo L. Congruency of Information Rather Than Body Ownership Enhances Motor Performance in Highly Embodied Virtual Reality. Front Neurosci. 2021 Jul 2;15:678909. doi: 10.3389/fnins.2021.678909. eCollection 2021.
Background: PubMed 12234086Gladstone DJ, Danells CJ, Black SE. The fugl-meyer assessment of motor recovery after stroke: a critical review of its measurement properties. Neurorehabil Neural Repair. 2002 Sep;16(3):232-40. doi: 10.1177/154596802401105171.
Background: PubMed 16296669Hsieh CL, Hsueh IP, Chiang FM, Lin PH. Inter-rater reliability and validity of the action research arm test in stroke patients. Age Ageing. 1998 Mar;27(2):107-13. doi: 10.1093/ageing/27.2.107.
Background: PubMed 18055266Dworkin RH, Turk DC, Wyrwich KW, Beaton D, Cleeland CS, Farrar JT, Haythornthwaite JA, Jensen MP, Kerns RD, Ader DN, Brandenburg N, Burke LB, Cella D, Chandler J, Cowan P, Dimitrova R, Dionne R, Hertz S, Jadad AR, Katz NP, Kehlet H, Kramer LD, Manning DC, McCormick C, McDermott MP, McQuay HJ, Patel S, Porter L, Quessy S, Rappaport BA, Rauschkolb C, Revicki DA, Rothman M, Schmader KE, Stacey BR, Stauffer JW, von Stein T, White RE, Witter J, Zavisic S. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J Pain. 2008 Feb;9(2):105-21. doi: 10.1016/j.jpain.2007.09.005. Epub 2007 Dec 11.
Derived from this study: PubMed 42362865Aurucci GV, Djordjevic O, Cimolato A, Secerovic N, Dimkic Tomic T, Ardura Carnicero MD, Yao H, Konstantinovic L, Raspopovic S. Immersive virtual reality with synchronous neurostimulation for upper-limb recovery after stroke: a randomized feasibility trial. Nat Med. 2026 Aug;32(8):2790-2802. doi: 10.1038/s41591-026-04486-4. Epub 2026 Jun 26.

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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.

Natalija Secerovic, PhD contact

+381631268862

natalija.katic@pupin.rs

Giuseppe Valerio Aurucci contact

+393931595791

valerioaurucci@gmail.com

Stanisa Raspopovic, PhD principal investigator

Mihajlo Pupin Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing VR+TENS and Conventional rehabilitation in people with Stroke, run by Institute Mihajlo Pupin at 1 site in Serbia.

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 5 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 9 Dec 2024. 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 Serbia. 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. 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 Natalija Secerovic, PhD (+381631268862, natalija.katic@pupin.rs), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in sensorimotor impairments (time frame: day 0 (before the first rehabilitation session, T0); 1.5 week (after six rehabilitation sessions, T1); 3 weeks (one day after the last rehabilitation session, T2); 5 weeks (2 weeks after the last rehabilitation session,T3)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06400823, which also lists 9 linked publications.

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 9 Dec 2024.