Combining virtual walking and brain stimulation for chronic pain from spinal cord injury
VIRTUAL WALKING and TRANSCRANIAL DIRECT CURRENT STIMULATION (TDCS) for CHRONIC NEUROPATHIC PAIN DUE to SPINAL CORD INJURY (SCI): a FEASIBILITY STUDY
This study is testing if combining virtual walking with brain stimulation can help people with spinal cord injuries manage their chronic pain better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 4 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Swiss Paraplegic Research, Nottwil Research network |
| Locations | 1 site (Nottwil) |
| Trial ID | NCT06710808 on ClinicalTrials.gov |
What this trial studies
This feasibility study aims to evaluate the combined treatment of virtual walking (VW) and transcranial direct current stimulation (tDCS) for managing chronic neuropathic pain in patients with spinal cord injury. Participants will undergo a two-week intervention at the Swiss Paraplegic Centre, receiving ten sessions of VW and tDCS, each lasting around 20 minutes. Throughout the study, participants will maintain a diary of their symptoms and complete questionnaires assessing pain intensity, chronicity, and psychological factors. Interviews will be conducted at the beginning and end of the study to gather insights on participants' expectations and the feasibility of the interventions.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with traumatic spinal cord injuries and chronic neuropathic pain of at least 4/10 intensity.
Not a fit: Patients with severe psychiatric disorders, previous brain surgeries, or certain metal implants may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel non-invasive treatment option for managing chronic neuropathic pain in spinal cord injury patients.
How similar studies have performed: While the combination of VW and tDCS is innovative, similar approaches in pain management have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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) * History of epilepsy or seizure * Pregnancy (anamnestic) * Inability to give consent
Where this trial is running
Nottwil
- Swiss Paraplegic Centre — Nottwil, Switzerland (Recruiting)
Study contacts
- Study coordinator: KD Dr. med. Gunther Landmann, MSc
- Email: gunther.landmann@paraplegie.ch
- Phone: +41 41 939 49 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.