Brain Activity Patterns in Persons With Spinal Cord Injury and Neuropathic Pain After a Virtual Walking Training Program

NCT05098587 | Completed DMC

• 1 other identifier: 2020-13
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Spinal Cord Injuries; Neuropathic Pain

Keywords

functional magnetic resonance imaging; brain activity patterns

Outcome Measures

Primary Outcomes (1)

• 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)

  Three measurement time points: Baseline (T1), six weeks after baseline (T2), ten weeks after after baseline (T3)

Secondary Outcomes (14)

• Change of Choline

  Three measurement time points: Baseline (T1), six weeks after baseline (T2), ten weeks after after baseline (T3)

• Alteration of Creatine

  Three measurement time points: Baseline (T1), six weeks after baseline (T2), ten weeks after after baseline (T3)

• Alteration of myo-Inositol

  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

  Three measurement time points: Baseline (T1), six weeks after baseline (T2), ten weeks after after baseline (T3)

• Pain diary

  Three measurement time points: Baseline (T1), six weeks after baseline (T2), ten weeks after after baseline (T3)

Other Outcomes (1)

• Sociodemographic and clinical characteristics

  At the beginning and at follow up.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Swiss Paraplegic Research, Nottwil: lead
• Haute Ecole de Santé Vaud: collaborator

Study Sites (1)

Swiss Paraplegic Centre; Centre for pain medicine

Nottwil, Canton of Lucerne, 6207, Switzerland

Location

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Related Links

• Declaration of Helsinki
• Ordinance on Human Research with the Exception of Clinical trials (HRO), swiss law
• Human Research Act (HRA), swiss law

MeSH Terms

Conditions

Spinal Cord Injuries; Neuralgia

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Peripheral Nervous System Diseases; Neuromuscular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2021
• First Posted: October 28, 2021
• Study Start: August 30, 2021
• Primary Completion: January 10, 2023
• Study Completion: January 10, 2023
• Last Updated: March 8, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)