Spinal Cord InjuryNCT06710808
VIRTUAL WALKING AND TRANSCRANIAL DIRECT CURRENT STIMULATION FOR CHRONIC NEUROPATHIC PAIN DUE TO SPINAL CORD INJURY
A study testing Virtual walking and transcranial direct current stimulation in people with Spinal Cord Injury and Chronic Neuropathic Pain, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
Trial summary
The goal of this feasibility study is to assess the feasibility of the combined treatment intervention "virtual walking (VW) and transcranial direct current stimulation (tDCS)" of neuropathic pain in patients with spinal cord injury. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Spinal Cord Injury, Chronic Neuropathic Pain
- What is being tested?
- Virtual walking and transcranial direct current stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Oct 2024to 1 Apr 2025
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18y, ≤ 75y
- traumatic SCI (> 6 month after SCI) with a SCI severity grade AIS A, B, C or D
- At or below level spinal cord injury neuropathic pain on trunk or lower extremities according to the ISCIP classification (Bryce et al., 2012) of at least 4/10 intensity on a NRS (Langford et al., 2023) with in the last 7 days (WiderströmNoga et al., 2023)
- Good communication in German to understand the instructions, assessments and to fill in questionnaires
- Adequate siting balance
- Ability to draw with a pencil
- Ability to swing arms
Who cannot join
- severe psychiatric disorder requiring psychiatric hospitalisation or mental disease that could interfere with their ability to participate
- Previous brain surgery
- Metal implants in the skull or brain, including cochlear implants, intracranial electrodes or a pacemaker (Datta et al., 2010)
- Drugs that affect cortical excitability (McLaren et al., 2018): Alcohol, Amphetamines, Theophylline (asthma treatment), Chlorpromazine, Clozapine, Amitriptyline, Doxepine, Imipramine, Maprotiline, Nortriptyline, Foscarnet, Ganciclovir, Ritonavir, Amphetamines, Cocaine, Gamma-hydroxybutyrate (GHB), Ketamine, MDMA, ecstasy Phencyclidine
- Previous adverse effects of stimulation with tDCS
- A scalp or skin condition (e.g. psoriasis or eczema)
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- History of epilepsy or seizure
- Pregnancy (anamnestic)
- Inability to give consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: VIRTUAL WALKING AND TRANSCRANIAL DIRECT CURRENT STIMULATION (TDCS) FOR CHRONIC NEUROPATHIC PAIN DUE TO SPINAL CORD INJURY (SCI): A FEASIBILITY STUDY
The goal of this feasibility study is to assess the feasibility of the combined treatment intervention "virtual walking (VW) and transcranial direct current stimulation (tDCS)" of neuropathic pain in patients with spinal cord injury. The main question aims to answer:
- To assess the feasibility of combining VW and tDCS for longer-term use from the patients' point of view.
Read more
Participants will:
Receive a two week intervention in the Swiss Paraplegic Centre in Nottwil, where the participants undergo VW and tDCS for ten sessions, each lasting around 20 minutes.
The participants keep a diary and a pain drawing of their symptoms and will fill out some questionnaires about their impression of feasibility, the pain intensity, chronicity, the impression of change, depression, anxiety, stress and adverse events. At the beginning and end of the study the participants will be interviewed about their expectations, hopes and the feasibility of the procedures from a participants point of view.
- Conditions
- Spinal Cord Injury, Chronic Neuropathic Pain
- Being tested
- Virtual walking and transcranial direct current stimulation
- Keywords
- Neuropathic pain, Chronic neuropathic pain, spinal cord injury, virtual walking, transcranial direct current stimulation, tDCS
- Medical subject headings
- Spinal Cord Injuries, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual walking and transcranial direct current stimulationOther
Participants will receive VW-therapy combined with tDCS. The intervention is adapted from Soler et al. 2010 and consists of 10 sessions over 2 weeks, each session lasting around 20 minutes.
For the virtual walking the participant sits on a modified wheelchair, which is positioned at a distance of two meters from the screen. The setting provides an illusion of a third person perspective and the participant can see himself/herself walk through a forest ambience.
The tDCS session is according the same protocol from Soler et al., 2010. Hereby, the device from Starstim, Neuroelectrics will be used, which is equipped with a neoprene cap containing electrodes. The anodes will be placed over C3 or C4 (EEG 10/20 system) to target the motor cortex (M1) contralateral to the painful side and the cathodes will be placed over the contralateral supraorbital area. Symmetric pain participants receive stimulation on the dominant hemisphere. The tDCS applies a constant current of 2 mA over 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Virtual walking and transcranial direct current stimulation of 2 milliampere for 20 minutes | Experimental | Not described Receives: Other: Virtual walking and transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-reported expectations, acceptability and satisfaction
semistructured interview
Measured: one week before treatment, 2 weeks during treatment, 1 week after treatment
Secondary outcomes (10)
Adherence rate
Measured: during 2 weeks treatment
Drop out rate
Measured: during 2 weeks treatment
Preparation time
Time for preparation of participant in minutes
Measured: during 2 weeks treatment
Quality of pain
Neuropathic Pain Symptom Inventory (NPSI)
Measured: one week pre-treatment, one week post-treatment
Pain distribution
size of the drawn area in pixels and percentage in relation to the total body chart indicated by patient into a pain drawing scheme
Measured: From enrollment to the end of study at 4 weeks
Pain intensity
Numeric Rating Scale (no pain to most imaginable pain)
Measured: Daily from enrollment to the end of study at 4 weeks
Patient Global Impression of Change (PGIC)
Subjective global impression of change after treatment
Measured: one week post-treatment
Depression, anxiety and stress
Depression Anxiety \& Stress Scale (DASS)
Measured: one week pre-treatment and one week post-treatment
Pain chronicity
Mainz Pain Staging System (MPSS)
Measured: one week pre-treatment
Safety of tDCS
Adverse events questionnaire
Measured: every day during the 2 weeks treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start1 Oct 2024
- Primary completion1 Apr 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Paraplegic Research, Nottwil
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06710808
- Sponsor's protocol ID
- 2024-12
- Status last verified
- Nov 2025
- First submitted
- 26 Nov 2024
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VIRTUAL WALKING AND TRANSCRANIAL DIRECT CURRENT STIMULATION (TDCS) FOR CHRONIC NEUROPATHIC PAIN DUE TO SPINAL CORD INJURY (SCI): A FEASIBILITY STUDY
- ClinicalTrials.gov ID
- NCT06710808
- Acronym / sponsor ID
- 2024-12
- Conditions
- Spinal Cord Injury, Chronic Neuropathic Pain
- Keywords
- Neuropathic pain, Chronic neuropathic pain, spinal cord injury, virtual walking, transcranial direct current stimulation, tDCS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Swiss Paraplegic Research, NottwilResearch network
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 29 Nov 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.
The goal of this feasibility study is to assess the feasibility of the combined treatment intervention "virtual walking (VW) and transcranial direct current stimulation (tDCS)" of neuropathic pain in patients with spinal cord injury. The main question aims to answer:
- To assess the feasibility of combining VW and tDCS for longer-term use from the patients' point of view.
Participants will:
Receive a two week intervention in the Swiss Paraplegic Centre in Nottwil, where the participants undergo VW and tDCS for ten sessions, each lasting around 20 minutes.
The participants keep a diary and a pain drawing of their symptoms and will fill out some questionnaires about their impression of feasibility, the pain intensity, chronicity, the impression of change, depression, anxiety, stress and adverse events. At the beginning and end of the study the participants will be interviewed about their expectations, hopes and the feasibility of the procedures from a participants point of view.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Virtual walking and transcranial direct current stimulation of 2 milliampere for 20 minutes | Experimental | Other: Virtual walking and transcranial direct current stimulation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18y, ≤ 75y
- traumatic SCI (> 6 month after SCI) with a SCI severity grade AIS A, B, C or D
- At or below level spinal cord injury neuropathic pain on trunk or lower extremities according to the ISCIP classification (Bryce et al., 2012) of at least 4/10 intensity on a NRS (Langford et al., 2023) with in the last 7 days (WiderströmNoga et al., 2023)
- Good communication in German to understand the instructions, assessments and to fill in questionnaires
- Adequate siting balance
Key exclusion criteria (9 listed)
- severe psychiatric disorder requiring psychiatric hospitalisation or mental disease that could interfere with their ability to participate
- Previous brain surgery
- Metal implants in the skull or brain, including cochlear implants, intracranial electrodes or a pacemaker (Datta et al., 2010)
- Drugs that affect cortical excitability (McLaren et al., 2018): Alcohol, Amphetamines, Theophylline (asthma treatment), Chlorpromazine, Clozapine, Amitriptyline, Doxepine, Imipramine, Maprotiline, Nortriptyline, Foscarnet, Ganciclovir, Ritonavir, Amphetamines, Cocaine, Gamma-hydroxybutyrate (GHB), Ketamine, MDMA, ecstasy Phencyclidine
- Previous adverse effects of stimulation with tDCS
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 walking and transcranial direct current stimulationParticipants will receive VW-therapy combined with tDCS. The intervention is adapted from Soler et al. 2010 and consists of 10 sessions over 2 weeks, each session lasting around 20 minutes. For the virtual walking the participant sits on a modified wheelchair, which is positioned at a distance of two meters from the screen. The setting provides an illusion of a third person perspective and the participant can see himself/herself walk through a forest ambience. The tDCS session is according the same protocol from Soler et al., 2010. Hereby, the device from Starstim, Neuroelectrics will be used, which is equipped with a neoprene cap containing electrodes. The anodes will be placed over C3 or C4 (EEG 10/20 system) to target the motor cortex (M1) contralateral to the painful side and the cathodes will be placed over the contralateral supraorbital area. Symmetric pain participants receive stimulation on the dominant hemisphere. The tDCS applies a constant current of 2 mA over 20 minutes. | Other | Virtual walking and transcranial direct current stimulation of 2 milliampere for 20 minutes |
Primary outcome
Patient-reported expectations, acceptability and satisfaction
Time frame: one week before treatment, 2 weeks during treatment, 1 week after treatment
semistructured interview
10 secondary outcomes
Adherence rate
Time frame: during 2 weeks treatment
Drop out rate
Time frame: during 2 weeks treatment
Preparation time
Time frame: during 2 weeks treatment
Quality of pain
Time frame: one week pre-treatment, one week post-treatment
Pain distribution
Time frame: From enrollment to the end of study at 4 weeks
Pain intensity
Time frame: Daily from enrollment to the end of study at 4 weeks
Patient Global Impression of Change (PGIC)
Time frame: one week post-treatment
Depression, anxiety and stress
Time frame: one week pre-treatment and one week post-treatment
Pain chronicity
Time frame: one week pre-treatment
Safety of tDCS
Time frame: every day during the 2 weeks treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 walking and transcranial direct current stimulation in people with Spinal Cord Injury and Chronic Neuropathic Pain, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
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 7 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: finished, as of the sponsor's last update on 20 Nov 2025. 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-reported expectations, acceptability and satisfaction (time frame: one week before treatment, 2 weeks during treatment, 1 week after treatment). 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 20 Nov 2025.