VIRTUAL WALKING and TRANSCRANIAL DIRECT CURRENT STIMULATION for CHRONIC NEUROPATHIC PAIN DUE to SPINAL CORD INJURY

Not Applicable

Recruiting

• Conditions: Spinal Cord Injury; Chronic Neuropathic Pain

• Registration Number: NCT06710808
• Lead Sponsor: Swiss Paraplegic Research, Nottwil

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study Start: 2024-11-12
• Study First Submitted: 2024-11-26
• Study First Submitted QC: 2024-11-26
• Last Update Submitted: 2024-11-26
• Study First Posted: 2024-11-28
• Last Update Posted: 2024-11-28
• Primary Completion: 2025-04-01
• Study Completion: 2025-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 4

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Patient-reported expectations, acceptability and satisfaction	one week before treatment, 2 weeks during treatment, 1 week after treatment	semistructured interview

Secondary Outcome Measures

Name	Time	Method
Adherence rate	during 2 weeks treatment
Drop out rate	during 2 weeks treatment
Quality of pain	one week pre-treatment, one week post-treatment	Neuropathic Pain Symptom Inventory (NPSI)
Preparation time	during 2 weeks treatment	Time for preparation of participant in minutes
Pain distribution	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
Pain intensity	Daily from enrollment to the end of study at 4 weeks	Numeric Rating Scale (no pain to most imaginable pain)
Pain chronicity	one week pre-treatment	Mainz Pain Staging System (MPSS)
Safety of tDCS	every day during the 2 weeks treatment	Adverse events questionnaire
Patient Global Impression of Change (PGIC)	one week post-treatment	Subjective global impression of change after treatment
Depression, anxiety and stress	one week pre-treatment and one week post-treatment	Depression Anxiety \& Stress Scale (DASS)

Trial Locations

Locations (1)

Swiss Paraplegic Centre; 🇨🇭 Nottwil, Switzerland