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

NCT06710808 | Completed DMC

• 1 other identifier: 2024-12
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spinal Cord Injury; Chronic Neuropathic Pain

Keywords

Neuropathic pain; Chronic neuropathic pain; spinal cord injury; virtual walking; transcranial direct current stimulation; tDCS

Outcome Measures

Primary Outcomes (1)

• Patient-reported expectations, acceptability and satisfaction

  semistructured interview

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

Secondary Outcomes (10)

• Adherence rate

  during 2 weeks treatment

• Drop out rate

  during 2 weeks treatment

• Preparation time

  during 2 weeks treatment

• Quality of pain

  one week pre-treatment, one week post-treatment

• Pain distribution

  From enrollment to the end of study at 4 weeks

Study Arms (1)

Virtual walking and transcranial direct current stimulation of 2 milliampere for 20 minutes

EXPERIMENTAL

Other: Virtual walking and transcranial direct current stimulation

Interventions

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.

Virtual walking and transcranial direct current stimulation of 2 milliampere for 20 minutes

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Swiss Paraplegic Research, Nottwil: lead

Study Sites (1)

Swiss Paraplegic Centre

Nottwil, 6207, Switzerland

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Neuralgia

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: November 29, 2024
• Study Start: October 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)