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Completed

NCT Number: NCT06710808

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

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.

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Key information

Conditions

Spinal Cord Injury Central Nervous System Diseases Chronic Neuropathic Pain Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Swiss Paraplegic Centre

Nottwil, 6207, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual walking and transcranial direct current stimulation

Other

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.

Primary outcomes

  1. Patient-reported expectations, acceptability and satisfaction

    Time frame: one week before treatment, 2 weeks during treatment, 1 week after treatment

    semistructured interview

Secondary outcomes

  1. Adherence rate

    Time frame: during 2 weeks treatment

  2. Drop out rate

    Time frame: during 2 weeks treatment

  3. Preparation time

    Time frame: during 2 weeks treatment

    Time for preparation of participant in minutes

  4. Quality of pain

    Time frame: one week pre-treatment, one week post-treatment

    Neuropathic Pain Symptom Inventory (NPSI)

  5. Pain distribution

    Time frame: From enrollment to the end of study at 4 weeks

    size of the drawn area in pixels and percentage in relation to the total body chart indicated by patient into a pain drawing scheme

  6. Pain intensity

    Time frame: Daily from enrollment to the end of study at 4 weeks

    Numeric Rating Scale (no pain to most imaginable pain)

  7. Patient Global Impression of Change (PGIC)

    Time frame: one week post-treatment

    Subjective global impression of change after treatment

  8. Depression, anxiety and stress

    Time frame: one week pre-treatment and one week post-treatment

    Depression Anxiety & Stress Scale (DASS)

  9. Pain chronicity

    Time frame: one week pre-treatment

    Mainz Pain Staging System (MPSS)

  10. Safety of tDCS

    Time frame: every day during the 2 weeks treatment

    Adverse events questionnaire

Sponsors and collaborators

Lead sponsor

Swiss Paraplegic Research, Nottwil

Network

Registry information

Official study title

VIRTUAL WALKING AND TRANSCRANIAL DIRECT CURRENT STIMULATION (TDCS) FOR CHRONIC NEUROPATHIC PAIN DUE TO SPINAL CORD INJURY (SCI): A FEASIBILITY STUDY

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 29, 2024
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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