VIRTUAL WALKING and TRANSCRANIAL DIRECT CURRENT STIMULATION for CHRONIC NEUROPATHIC PAIN DUE to SPINAL CORD INJURY
NCT ID: NCT06710808
Last Updated: 2024-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
4 participants
INTERVENTIONAL
2024-11-12
2025-04-01
Brief Summary
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• 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
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
OTHER
NONE
Study Groups
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Virtual walking and transcranial direct current stimulation of 2 milliampere for 20 minutes
Virtual walking and transcranial direct current stimulation
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.
Interventions
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Virtual walking and transcranial direct current stimulation
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Swiss Paraplegic Research, Nottwil
NETWORK
Responsible Party
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Locations
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Swiss Paraplegic Centre
Nottwil, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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KD Dr. med. Gunther Landmann, MSc
Role: primary
Other Identifiers
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2024-12
Identifier Type: -
Identifier Source: org_study_id