Spinal Cord InjuriesVRandMRINCT05098587
Brain Activity Patterns in Persons With Spinal Cord Injury and Neuropathic Pain After a Virtual Walking Training Program
An observational study of Spinal Cord Injuries and Neuropathic Pain, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
Trial summary
The aim of this pilot study is to explore the association of changes in pain perception with changes in brain activity (functional Magnetic Resonance Imaging (fMRI)) and metabolic (Magnetic Resonance Spectroscopy (MRS)) patterns of individuals with SCI and chronic NeP after a Virtual Walk (VW) therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries, Neuropathic Pain
- How many people
- 12 participants
- Where
- 1 siteSwitzerland
- Study dates
- 30 Aug 2021to 10 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Twelve individuals with SCI and NeP will be recruited at the Centre for Pain Medicine, Swiss Paraplegic Centre, Nottwil. A neurologist will check for inclusion and exclusion criteria. Patients, who will be screened routineously as part of the ordinary clinical visit by a neurologist, a physiotherapist and a psychologist for their eligibility to take part in the clinical VW program, will additionally be screened for their participation in the intended study. These assessments include checking inclusion and exclusion criteria and a diagnosis using the SCI pain basic dataset 2.0.
Who may be able to join
- Passed neurological, physiotherapeutic and psychological assessments and team decision to take part on VW
- Age ≧ 18
- Traumatic SCI (> 1 year) confirmed by MRI or CT
- Neuropathic at or below level spinal cord injury pain for at least 3 months diagnosed by a neurologist following the CanPain Clinical Practice Guidelines and ISCIP classification
- Good German skills (understand questionnaires and instructions)
- Ability to draw with a pen
- Ability to swing the arms
Who cannot join
- Claustrophobia
- Non-acceptance of the paraplegia
- Psychiatric disorders
- Epilepsy
- Other neurological, psycho-logical or cognitive impairments
- Pregnancy
- Spasticity that would interfere with MRI
- Extensive dose of opioids
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Swiss Paraplegic Centre; Centre for pain medicine
Nottwil, Canton of Lucerne, 6207
About this study
Official title: Are Changes in Pain Perception Associated With Changes in Brain Activity Patterns in Persons With Spinal Cord Injury and Neuropathic Pain After a Virtual Walking Training Program - A Pilot Study
The aim of this pilot study is to explore the association of changes in pain perception with changes in brain activity (functional Magnetic Resonance Imaging (fMRI)) and metabolic (Magnetic Resonance Spectroscopy (MRS)) patterns of individuals with SCI and chronic NeP after a Virtual Walk (VW) therapy. The brain activity patterns will be assessed in resting state and under a specific task, before and after a VW training program, done as part of the clinical routine, as well as at a four weeks follow-up.
The results of this pilot study will serve as basis for a bigger project that aims to investigate and compare brain activity and long-term effects of non-immersive VW therapy on chronic NeP in individuals with SCI (traumatic SCI with chronic NeP at- or below level, complete or incomplete) taking into account confounding factors such as time since injury, level of injury and type of NeP.
Read the detailed description
This pilot study consists of specific assessments at four different time points (T0=screening, T1=baseline, pre measurement, T2=post measurement, T3=four week follow-up).
The physiotherapeutical assessment at T0 involves the evaluation of the imagery capacity. At T1, the participant will be assessed for baseline measures before starting with the VW training. At T2 (after the last VW training) and at T3 (four weeks after the last VW training), the participant will be assessed for outcome measures.
Sociodemographic and clinical characteristics (age, sex, education level, workability, age at injury, lesion level, comorbidities, complications, concomitant injuries, SCI pain basic dataset 2.0 and medication) will be collected in the screening/recruitment phase but only used after receiving informed consent from each participant.
Participants will undergo a non-invasively MRI examination without application of contrast agents. The functional activity of the brain will be assessed by a blood oxygenation level-dependent (BOLD) fMRI. The metabolic profile will be assessed non-invasively by means of single voxel MRS. Prior to the fMRI and MRS measurements, a high-resolution anatomical MRI will be performed, which serves for tissue segmentation and planning purposes.
The MRI will consist out of the following sequences conducted in an MRI scanner (six minutes duration each):
- MRS sequence: The metabolic profile will be assessed with single voxel spectroscopy in the Anterior Cingulate Cortex and the Thalamus.
- Resting-state fMRI: The participant will stay rested with open eyes and does not have to perform a specific task.
- Task-based fMRI: In an on-off scheme, a sequence of neutral (not pain related) pictures on a screen, mounted outside of the MRI machine will be shown. The pictures will change every 20 seconds in a random order to keep the participant alert.
- Task-based fMRI: In an on-off scheme, a sequence of pain-related pictures on a screen, mounted outside of the MRI machine will be shown. The pictures will change every 20 seconds in a random order to keep the participant alert.
- Resting-state fMRI: The participant will stay rested with open eyes and does not have to execute a task.
The pain images shown during the task-based fMRI are a validated set of pictures.
The participants will receive a pain diary. This pain diary is filled in daily for the one-week period before the baseline assessments, during the VW therapy and in the week before the last assessments at T3. To minimise the risk of missing data in the pain diary the participants will be called one week before T3 and get reminded to fill in the pain diary.
Before starting with the VW therapy the participants will first perform a subitem of the standardised Graded Motor Imagery (GMI) training over four weeks, five times a day using the Recognise Foot App and the Recognise Hand App. The participants will train their capacity to perform a left-right discrimination for hands and feet. This training will help to improve the therapeutic effect of the following VW therapy program, by improving the imagery capacity. Reaction time as well as accuracy while performing a left-right discrimination task will be measured. More than 80% correct answers and a reaction time of less than two seconds is interpreted as good imagery capacity. The imagery capacity will be assessed right before the start of the discrimination training, after two weeks and after four weeks. This serves on one hand as information about participant characteristics and on the other hand as a control mechanism that each participant keeps performing this training.
After the discrimination training, the participants will perform a non-immersive VW therapy program at the pain clinic, which consists of five sessions of 10 to 20 minutes per week, over a two-week period, then three treatments per week for the following two weeks and finally in the last two weeks only two treatments per week are scheduled. This is the standard protocol for this kind of therapy and is not changed in any way for the participants of the MRI study. For the VW, the participants will sit on an electric wheelchair in front of a canvas with an integrated camera. The camera films the participant's head and trunk, which are then projected on the canvas, overlapping with the recording of the feet of an actor walking. This way the participants will see themselves walk through a forest from a third-person view. To improve the embodiment, the participants will be asked to swing their arms in the rhythm of the gait and imagine that they are walking themselves through the forest. In addition to this, the chair moves minimally in the frontal plane to imitate the natural movements of the pelvis while walking.
- Conditions
- Spinal Cord Injuries, Neuropathic Pain
- Keywords
- functional magnetic resonance imaging, brain activity patterns
- Medical subject headings
- Spinal Cord Injuries, Neuralgia
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of N-Acetyl-Aspartate in the anterior cingulate cortex
Non-invasive MRI-based metabolic marker measured under various conditions (resting state, painful images, non-painful images)
Measured: Three measurement time points: Baseline (T1), six weeks after baseline (T2), ten weeks after after baseline (T3)
Secondary outcomes (14)
Change of Choline
Non-invasive MRI-based metabolic marker (resting state, painful images, non-painful images)
Measured: Three measurement time points: Baseline (T1), six weeks after baseline (T2), ten weeks after after baseline (T3)
Alteration of Creatine
Non-invasive MRI-based metabolic marker
Measured: Three measurement time points: Baseline (T1), six weeks after baseline (T2), ten weeks after after baseline (T3)
Alteration of myo-Inositol
Non-invasive MRI-based metabolic marker
Measured: Three measurement time points: Baseline (T1), six weeks after baseline (T2), ten weeks after after baseline (T3)
BOLD signal changes during task-based and resting state functional MRI
Task-based and resting state functional MRI sequences are applied and BOLD signal changes are examined. A whole-brain and seed-based connectivity analysis are used and linked to pain processing and perception.
Measured: Three measurement time points: Baseline (T1), six weeks after baseline (T2), ten weeks after after baseline (T3)
Pain diary
A pain diary using the numeric pain rating scale from 0 = "no pain at all" to 10 = "worst imaginable pain", to assess pain intensity during the course of the study and in follow-up.
Measured: Three measurement time points: Baseline (T1), six weeks after baseline (T2), ten weeks after after baseline (T3)
Pain description list
Questionnaire containing 12 descriptions of pain to assess the quality of pain (how the pain is perceived) Patients have to rate each description on a scale ranging from 0 = "completely disagree" to 3 = "fully agree" Items 1 to 8 are only descriptively evaluated. The sum of items 9 to 12 is the affective score whereas a high value is indicating a high affective burden and a low value is equal to a low affective burden.
Measured: Three measurement time points: Baseline (T1), six weeks after baseline (T2), ten weeks after after baseline (T3)
Chronic pain grading scale
Questionnaire to assess the severity of chronic pain and its impact on daily activities containing 7 items that must be rated on a NRS ranging from 0 = "no pain", "no limitation"; to 10 = "worst imaginable pain"/limitation". Higher values thus indicating more pain/limitation.
Measured: Three measurement time points: Baseline (T1), six weeks after baseline (T2), ten weeks after after baseline (T3)
The Marburg questionnaire on habitual health findings
Questionnaire to assess general wellbeing containing 7 items that have to be rated on a rating scale ranging from 0 = "completely disagree" to 5 = "completely agree". A high score in this questionnaire indicates high well-being.
Measured: Three measurement time points: Baseline (T1), six weeks after baseline (T2), ten weeks after after baseline (T3)
WHO-QoL-BREF
Questionnaire containing 26 items to assess quality of life rated on a rating scale ranging from 1 = "very bad"/"very unhappy"/"not at all"/"never" to 5 = "very good"/"very happy"/"absolutely"/"always". Depending on the statements the scores have to be inversed to calculate the score. Higher scores indicate better quality of life. There are four domain scores that result from this questionnaire: physical domain, psychological domain, social relationships domain and environment domain.
Measured: Three measurement time points: Baseline (T1), six weeks after baseline (T2), ten weeks after after baseline (T3)
Pain catastrophizing scale
Questionnaire containing 13 items/statements to assess pain catastrophizing on a rating scale ranging from 0 = "never true" to 4 = "always true". A high score indicates a high degree of pain catastrophizing.
Measured: Three measurement time points: Baseline (T1), six weeks after baseline (T2), ten weeks after after baseline (T3)
Questions about pain chronification
Questionnaire to assess pain chronification consisting of ten questions. The single questions help to classify the stadium of pain chronification ranging from stadium I = mild chronification to stadium III = heavy chronification.
Measured: Three measurement time points: Baseline (T1), six weeks after baseline (T2), ten weeks after after baseline (T3)
SCI independence measure III - self-reported version
Questionnaire addressing the functional impairment including 17 items assessing the grade of necessary aid versus ability to do it on their own for specific daily activities with ratings ranging from 0 = "not able to do a task" to 8 = "no or minimal aid". The higher the score the more independent the person.
Measured: Three measurement time points: Baseline (T1), six weeks after baseline (T2), ten weeks after after baseline (T3)
Depression, Anxiety & Stress Scale
Questionnaire to assess depression, anxiety and stress using 21 items rated on a scale from 0 = "absolutely disagree" or "never" to 3 = "strong agreement" or "most of the time". Because the items are negatively formulated a high score indicates a high grade of depression, anxiety or stress. Each domain score consists of 7 items.
Measured: Three measurement time points: Baseline (T1), six weeks after baseline (T2), ten weeks after after baseline (T3)
Patient Global Impression of Change
One question to assess the subjective global impression of change after the therapy. The choice options range from "very much better than before" to "very much worse than before" with "unchanged" as the middle/neutral value.
Measured: Two measurement time points: only T2 (six weeks after baseline) and T3 (ten weeks after baseline))
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2021
- Study start30 Aug 2021
- Primary completion10 Jan 2023
- Study completion10 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Paraplegic Research, Nottwil
- Sponsor type
- Research network
- Collaborators
- Haute Ecole de Santé Vaud
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05098587
- Sponsor's protocol ID
- 2020-13
- Acronym
- VRandMRI
- Status last verified
- Mar 2024
- First submitted
- 13 Sep 2021
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bryce TN, Ragnarsson KT. Pain after spinal cord injury. Phys Med Rehabil Clin N Am. 2000 Feb;11(1):157-68.
PubMed 10680163Fekete C, Eriks-Hoogland I, Baumberger M, Catz A, Itzkovich M, Luthi H, Post MW, von Elm E, Wyss A, Brinkhof MW. Development and validation of a self-report version of the Spinal Cord Independence Measure (SCIM III). Spinal Cord. 2013 Jan;51(1):40-7. doi: 10.1038/sc.2012.87. Epub 2012 Aug 14.
PubMed 22890418Finnerup NB, Attal N, Haroutounian S, McNicol E, Baron R, Dworkin RH, Gilron I, Haanpaa M, Hansson P, Jensen TS, Kamerman PR, Lund K, Moore A, Raja SN, Rice AS, Rowbotham M, Sena E, Siddall P, Smith BH, Wallace M. Pharmacotherapy for neuropathic pain in adults: a systematic review and meta-analysis. Lancet Neurol. 2015 Feb;14(2):162-73. doi: 10.1016/S1474-4422(14)70251-0. Epub 2015 Jan 7.
PubMed 25575710Guy SD, Mehta S, Casalino A, Cote I, Kras-Dupuis A, Moulin DE, Parrent AG, Potter P, Short C, Teasell R, Bradbury CL, Bryce TN, Craven BC, Finnerup NB, Harvey D, Hitzig SL, Lau B, Middleton JW, O'Connell C, Orenczuk S, Siddall PJ, Townson A, Truchon C, Widerstrom-Noga E, Wolfe D, Loh E. The CanPain SCI Clinical Practice Guidelines for Rehabilitation Management of Neuropathic Pain after Spinal Cord: Recommendations for treatment. Spinal Cord. 2016 Aug;54 Suppl 1:S14-23. doi: 10.1038/sc.2016.90.
PubMed 27444715Jackson PL, Meltzoff AN, Decety J. How do we perceive the pain of others? A window into the neural processes involved in empathy. Neuroimage. 2005 Feb 1;24(3):771-9. doi: 10.1016/j.neuroimage.2004.09.006.
PubMed 15652312Klasen BW, Hallner D, Schaub C, Willburger R, Hasenbring M. Validation and reliability of the German version of the Chronic Pain Grade questionnaire in primary care back pain patients. Psychosoc Med. 2004 Oct 14;1:Doc07.
PubMed 19742049Kleinloog D, Rombouts S, Zoethout R, Klumpers L, Niesters M, Khalili-Mahani N, Dahan A, van Gerven J. Subjective Effects of Ethanol, Morphine, Delta(9)-Tetrahydrocannabinol, and Ketamine Following a Pharmacological Challenge Are Related to Functional Brain Connectivity. Brain Connect. 2015 Dec;5(10):641-8. doi: 10.1089/brain.2014.0314. Epub 2015 Sep 21.
PubMed 26390148Mehta S, Guy SD, Bryce TN, Craven BC, Finnerup NB, Hitzig SL, Orenczuk S, Siddall PJ, Widerstrom-Noga E, Casalino A, Cote I, Harvey D, Kras-Dupuis A, Lau B, Middleton JW, Moulin DE, O'Connell C, Parrent AG, Potter P, Short C, Teasell R, Townson A, Truchon C, Wolfe D, Bradbury CL, Loh E. The CanPain SCI Clinical Practice Guidelines for Rehabilitation Management of Neuropathic Pain after Spinal Cord: screening and diagnosis recommendations. Spinal Cord. 2016 Aug;54 Suppl 1:S7-S13. doi: 10.1038/sc.2016.89.
PubMed 27444717Meyer K, Sprott H, Mannion AF. Cross-cultural adaptation, reliability, and validity of the German version of the Pain Catastrophizing Scale. J Psychosom Res. 2008 May;64(5):469-78. doi: 10.1016/j.jpsychores.2007.12.004.
PubMed 18440399Reckziegel D, Vachon-Presseau E, Petre B, Schnitzer TJ, Baliki MN, Apkarian AV. Deconstructing biomarkers for chronic pain: context- and hypothesis-dependent biomarker types in relation to chronic pain. Pain. 2019 May;160 Suppl 1(Suppl 1):S37-S48. doi: 10.1097/j.pain.0000000000001529.
PubMed 31008848Siddall PJ, McClelland JM, Rutkowski SB, Cousins MJ. A longitudinal study of the prevalence and characteristics of pain in the first 5 years following spinal cord injury. Pain. 2003 Jun;103(3):249-257. doi: 10.1016/S0304-3959(02)00452-9.
PubMed 12791431Turk DC, Dworkin RH, Allen RR, Bellamy N, Brandenburg N, Carr DB, Cleeland C, Dionne R, Farrar JT, Galer BS, Hewitt DJ, Jadad AR, Katz NP, Kramer LD, Manning DC, McCormick CG, McDermott MP, McGrath P, Quessy S, Rappaport BA, Robinson JP, Royal MA, Simon L, Stauffer JW, Stein W, Tollett J, Witter J. Core outcome domains for chronic pain clinical trials: IMMPACT recommendations. Pain. 2003 Dec;106(3):337-345. doi: 10.1016/j.pain.2003.08.001.
PubMed 14659516Upadhyay J, Maleki N, Potter J, Elman I, Rudrauf D, Knudsen J, Wallin D, Pendse G, McDonald L, Griffin M, Anderson J, Nutile L, Renshaw P, Weiss R, Becerra L, Borsook D. Alterations in brain structure and functional connectivity in prescription opioid-dependent patients. Brain. 2010 Jul;133(Pt 7):2098-114. doi: 10.1093/brain/awq138. Epub 2010 Jun 16.
PubMed 20558415Widerstrom-Noga E, Biering-Sorensen F, Bryce TN, Cardenas DD, Finnerup NB, Jensen MP, Richards JS, Siddall PJ. The International Spinal Cord Injury Pain Basic Data Set (version 2.0). Spinal Cord. 2014 Apr;52(4):282-6. doi: 10.1038/sc.2014.4. Epub 2014 Jan 28.
PubMed 24469147Whitfield-Gabrieli S, Nieto-Castanon A. Conn: a functional connectivity toolbox for correlated and anticorrelated brain networks. Brain Connect. 2012;2(3):125-41. doi: 10.1089/brain.2012.0073. Epub 2012 Jul 19.
PubMed 22642651
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are Changes in Pain Perception Associated With Changes in Brain Activity Patterns in Persons With Spinal Cord Injury and Neuropathic Pain After a Virtual Walking Training Program - A Pilot Study
- ClinicalTrials.gov ID
- NCT05098587
- Acronym / sponsor ID
- VRandMRI / 2020-13
- Conditions
- Spinal Cord Injuries, Neuropathic Pain
- Keywords
- functional magnetic resonance imaging, brain activity patterns
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Swiss Paraplegic Research, NottwilResearch network
- Collaborators
- Haute Ecole de Santé Vaud
- Study start
- 30 Aug 2021 (actual)
- Primary completion
- 10 Jan 2023 (actual)
- Study completion
- 10 Jan 2023 (actual)
- First posted
- 28 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this pilot study is to explore the association of changes in pain perception with changes in brain activity (functional Magnetic Resonance Imaging (fMRI)) and metabolic (Magnetic Resonance Spectroscopy (MRS)) patterns of individuals with SCI and chronic NeP after a Virtual Walk (VW) therapy. The brain activity patterns will be assessed in resting state and under a specific task, before and after a VW training program, done as part of the clinical routine, as well as at a four weeks follow-up.
The results of this pilot study will serve as basis for a bigger project that aims to investigate and compare brain activity and long-term effects of non-immersive VW therapy on chronic NeP in individuals with SCI (traumatic SCI with chronic NeP at- or below level, complete or incomplete) taking into account confounding factors such as time since injury, level of injury and type of NeP.
Detailed description
This pilot study consists of specific assessments at four different time points (T0=screening, T1=baseline, pre measurement, T2=post measurement, T3=four week follow-up).
The physiotherapeutical assessment at T0 involves the evaluation of the imagery capacity. At T1, the participant will be assessed for baseline measures before starting with the VW training. At T2 (after the last VW training) and at T3 (four weeks after the last VW training), the participant will be assessed for outcome measures.
Sociodemographic and clinical characteristics (age, sex, education level, workability, age at injury, lesion level, comorbidities, complications, concomitant injuries, SCI pain basic dataset 2.0 and medication) will be collected in the screening/recruitment phase but only used after receiving informed consent from each participant.
Participants will undergo a non-invasively MRI examination without application of contrast agents. The functional activity of the brain will be assessed by a blood oxygenation level-dependent (BOLD) fMRI. The metabolic profile will be assessed non-invasively by means of single voxel MRS. Prior to the fMRI and MRS measurements, a high-resolution anatomical MRI will be performed, which serves for tissue segmentation and planning purposes.
The MRI will consist out of the following sequences conducted in an MRI scanner (six minutes duration each):
- MRS sequence: The metabolic profile will be assessed with single voxel spectroscopy in the Anterior Cingulate Cortex and the Thalamus.
- Resting-state fMRI: The participant will stay rested with open eyes and does not have to perform a specific task.
- Task-based fMRI: In an on-off scheme, a sequence of neutral (not pain related) pictures on a screen, mounted outside of the MRI machine will be shown. The pictures will change every 20 seconds in a random order to keep the participant alert.
- Task-based fMRI: In an on-off scheme, a sequence of pain-related pictures on a screen, mounted outside of the MRI machine will be shown. The pictures will change every 20 seconds in a random order to keep the participant alert.
- Resting-state fMRI: The participant will stay rested with open eyes and does not have to execute a task.
The pain images shown during the task-based fMRI are a validated set of pictures.
The participants will receive a pain diary. This pain diary is filled in daily for the one-week period before the baseline assessments, during the VW therapy and in the week before the last assessments at T3. To minimise the risk of missing data in the pain diary the participants will be called one week before T3 and get reminded to fill in the pain diary.
Before starting with the VW therapy the participants will first perform a subitem of the standardised Graded Motor Imagery (GMI) training over four weeks, five times a day using the Recognise Foot App and the Recognise Hand App. The participants will train their capacity to perform a left-right discrimination for hands and feet. This training will help to improve the therapeutic effect of the following VW therapy program, by improving the imagery capacity. Reaction time as well as accuracy while performing a left-right discrimination task will be measured. More than 80% correct answers and a reaction time of less than two seconds is interpreted as good imagery capacity. The imagery capacity will be assessed right before the start of the discrimination training, after two weeks and after four weeks. This serves on one hand as information about participant characteristics and on the other hand as a control mechanism that each participant keeps performing this training.
After the discrimination training, the participants will perform a non-immersive VW therapy program at the pain clinic, which consists of five sessions of 10 to 20 minutes per week, over a two-week period, then three treatments per week for the following two weeks and finally in the last two weeks only two treatments per week are scheduled. This is the standard protocol for this kind of therapy and is not changed in any way for the participants of the MRI study. For the VW, the participants will sit on an electric wheelchair in front of a canvas with an integrated camera. The camera films the participant's head and trunk, which are then projected on the canvas, overlapping with the recording of the feet of an actor walking. This way the participants will see themselves walk through a forest from a third-person view. To improve the embodiment, the participants will be asked to swing their arms in the rhythm of the gait and imagine that they are walking themselves through the forest. In addition to this, the chair moves minimally in the frontal plane to imitate the natural movements of the pelvis while walking.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Twelve individuals with SCI and NeP will be recruited at the Centre for Pain Medicine, Swiss Paraplegic Centre, Nottwil. A neurologist will check for inclusion and exclusion criteria. Patients, who will be screened routineously as part of the ordinary clinical visit by a neurologist, a physiotherapist and a psychologist for their eligibility to take part in the clinical VW program, will additionally be screened for their participation in the intended study. These assessments include checking inclusion and exclusion criteria and a diagnosis using the SCI pain basic dataset 2.0.
Key inclusion criteria (7 listed)
- Passed neurological, physiotherapeutic and psychological assessments and team decision to take part on VW
- Age ≧ 18
- Traumatic SCI (> 1 year) confirmed by MRI or CT
- Neuropathic at or below level spinal cord injury pain for at least 3 months diagnosed by a neurologist following the CanPain Clinical Practice Guidelines and ISCIP classification
- Good German skills (understand questionnaires and instructions)
Key exclusion criteria (8 listed)
- Claustrophobia
- Non-acceptance of the paraplegia
- Psychiatric disorders
- Epilepsy
- Other neurological, psycho-logical or cognitive impairments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change of N-Acetyl-Aspartate in the anterior cingulate cortex
Time frame: Three measurement time points: Baseline (T1), six weeks after baseline (T2), ten weeks after after baseline (T3)
Non-invasive MRI-based metabolic marker measured under various conditions (resting state, painful images, non-painful images)
14 secondary outcomes
Change of Choline
Time frame: Three measurement time points: Baseline (T1), six weeks after baseline (T2), ten weeks after after baseline (T3)
Alteration of Creatine
Time frame: Three measurement time points: Baseline (T1), six weeks after baseline (T2), ten weeks after after baseline (T3)
Alteration of myo-Inositol
Time frame: Three measurement time points: Baseline (T1), six weeks after baseline (T2), ten weeks after after baseline (T3)
BOLD signal changes during task-based and resting state functional MRI
Time frame: Three measurement time points: Baseline (T1), six weeks after baseline (T2), ten weeks after after baseline (T3)
Pain diary
Time frame: Three measurement time points: Baseline (T1), six weeks after baseline (T2), ten weeks after after baseline (T3)
Pain description list
Time frame: Three measurement time points: Baseline (T1), six weeks after baseline (T2), ten weeks after after baseline (T3)
Chronic pain grading scale
Time frame: Three measurement time points: Baseline (T1), six weeks after baseline (T2), ten weeks after after baseline (T3)
The Marburg questionnaire on habitual health findings
Time frame: Three measurement time points: Baseline (T1), six weeks after baseline (T2), ten weeks after after baseline (T3)
WHO-QoL-BREF
Time frame: Three measurement time points: Baseline (T1), six weeks after baseline (T2), ten weeks after after baseline (T3)
Pain catastrophizing scale
Time frame: Three measurement time points: Baseline (T1), six weeks after baseline (T2), ten weeks after after baseline (T3)
Questions about pain chronification
Time frame: Three measurement time points: Baseline (T1), six weeks after baseline (T2), ten weeks after after baseline (T3)
SCI independence measure III - self-reported version
Time frame: Three measurement time points: Baseline (T1), six weeks after baseline (T2), ten weeks after after baseline (T3)
Depression, Anxiety & Stress Scale
Time frame: Three measurement time points: Baseline (T1), six weeks after baseline (T2), ten weeks after after baseline (T3)
Patient Global Impression of Change
Time frame: Two measurement time points: only T2 (six weeks after baseline) and T3 (ten weeks after baseline))
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Background: PubMed 10680163Bryce TN, Ragnarsson KT. Pain after spinal cord injury. Phys Med Rehabil Clin N Am. 2000 Feb;11(1):157-68.
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- Declaration of HelsinkiLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injuries and Neuropathic Pain, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of N-Acetyl-Aspartate in the anterior cingulate cortex (time frame: Three measurement time points: Baseline (T1), six weeks after baseline (T2), ten weeks after after baseline (T3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05098587, which also lists 30 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2024.