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

Swiss Paraplegic Research, Nottwil

Status: Completed

Conditions: Chronic Neuropathic Pain; Spinal Cord Injury

Treatments: Other: Virtual walking and transcranial direct current stimulation

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT06710808

2024-12

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

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

Experimental group

Treatment:

Other: Virtual walking and transcranial direct current stimulation