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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual walking and transcranial direct current stimulation of 2 milliampere for 20 minutes | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-reported expectations, acceptability and satisfaction | semistructured interview | one week before treatment, 2 weeks during treatment, 1 week after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence rate | during 2 weeks treatment | |
| Drop out rate | during 2 weeks treatment | |
| Preparation time |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Swiss Paraplegic Centre | Nottwil | 6207 | Switzerland |
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|
Time for preparation of participant in minutes
| during 2 weeks treatment |
| Quality of pain | Neuropathic Pain Symptom Inventory (NPSI) | one week pre-treatment, one week post-treatment |
| Pain distribution | size of the drawn area in pixels and percentage in relation to the total body chart indicated by patient into a pain drawing scheme | From enrollment to the end of study at 4 weeks |
| Pain intensity | Numeric Rating Scale (no pain to most imaginable pain) | Daily from enrollment to the end of study at 4 weeks |
| Patient Global Impression of Change (PGIC) | Subjective global impression of change after treatment | one week post-treatment |
| Depression, anxiety and stress | Depression Anxiety & Stress Scale (DASS) | one week pre-treatment and one week post-treatment |
| Pain chronicity | Mainz Pain Staging System (MPSS) | one week pre-treatment |
| Safety of tDCS | Adverse events questionnaire | every day during the 2 weeks treatment |
| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |
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