CompletedNot Applicable

VIRTUAL WALKING AND TRANSCRANIAL DIRECT CURRENT STIMULATION FOR CHRONIC NEUROPATHIC PAIN DUE TO SPINAL CORD INJURY

Switzerland4 participantsStarted 2024-10-01

Plain-language 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. 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Patient-reported expectations, acceptability and satisfaction

Timeframe: one week before treatment, 2 weeks during treatment, 1 week after treatment

Trial details

NCT IDNCT06710808

SponsorSwiss Paraplegic Research, Nottwil

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2025-04-01