Clinical trial NCT06710808: VIRTUAL WALKING and TRANSCRANIAL DIRECT CURRENT STIMULATION for CHRONIC NEUROPATHIC PAIN DUE to SPINAL CORD INJURY
Official title: VIRTUAL WALKING and TRANSCRANIAL DIRECT CURRENT STIMULATION (TDCS) for CHRONIC NEUROPATHIC PAIN DUE to SPINAL CORD INJURY (SCI): a FEASIBILITY STUDY
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Cord Injury
Chronic Neuropathic Pain
Keywords: Neuropathic pain
Chronic neuropathic pain
spinal cord injury
virtual walking
transcranial direct current stimulation
tDCS
Lead sponsor: Swiss Paraplegic Research, Nottwil
Sponsor class: NETWORK
First posted: 2024-11-29
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Patient-reported expectations, acceptability and satisfaction
timeFrame: one week before treatment, 2 weeks during treatment, 1 week after treatment
Secondary outcomes:
measure: Adherence rate
timeFrame: during 2 weeks treatment
measure: Drop out rate
timeFrame: during 2 weeks treatment
measure: Preparation time
timeFrame: during 2 weeks treatment
measure: Quality of pain
timeFrame: one week pre-treatment, one week post-treatment
measure: Pain distribution
timeFrame: From enrollment to the end of study at 4 weeks
measure: Pain intensity
timeFrame: Daily from enrollment to the end of study at 4 weeks
measure: Patient Global Impression of Change (PGIC)
timeFrame: one week post-treatment
measure: Depression, anxiety and stress
timeFrame: one week pre-treatment and one week post-treatment
measure: Pain chronicity
timeFrame: one week pre-treatment
measure: Safety of tDCS
timeFrame: every day during the 2 weeks treatment
Other outcomes:
Locations:
city: Nottwil
country: Switzerland
facility: Swiss Paraplegic Centre
Study officials:
References: