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NCT Number: NCT05545358

Neural Bases of Phantom Pain After Amputation

The amputation of a limb results in chronic pain associated with the lost limb in the majority of patients, which persists over time. Despite a large number of studies conducted in an attempt to elucidate the neural basis of phantom pain, these are still not elucidated and current treatments often fail to relieve patients' pain.

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Key information

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Between 18 and 65 years old
  • For the "amputees with phantom pain" group: patients who have been amputated for more than 2 years and have chronic phantom pain
  • For the "amputees without phantom pain" group: patients who have been amputated for more than 2 years and do not have chronic phantom pain
  • For the "healthy participants" group: healthy participants with no neurological history

Exclusion criteria

  • Clinically significant pathology (gastrointestinal, renal, hepatic, endocrine, cardiovascular or respiratory)
  • Progressive psychiatric or neurological pathology
  • On psychotropic medication
  • Pregnant or nursing woman
  • Inadequate level of French language

Treatment and study plan

questionnaires

Other

Short-Form McGill Pain Questionnaire (SF-MPQ) Pain Disability Index (PDI) Prosthesis Evaluation Questionnaire (PEQ) Psychological Inflexibility to Pain Scale (PIPS) Chronic Pain Acceptance Questionnaire (CPAQ) Cognitive Difficulties Scale (CDS) Amputee Body Image Scale (ABIS) Trinity Amputation and Prosthesis Experience Scales (TAPES) Pain Catastrophizing Scale (PCS) Hospital Anxiety and Depression Scale (HAD) Credibility/Expectancy Questionnaire (CEQ) Short-Form Edinburgh Handedness Inventory (SF-EHI) Patient's Global Impression of Change (PGIC)

Brain and Spinal Cord functional Magnetic Resonance Imaging

Device

Brain and Spinal Cord functional Magnetic Resonance Imaging

Proprioceptive training

Other

Proprioceptive muscular training via a mechanical vibration of low amplitude and frequency between 60 and 80 Hz applied to the tendons.

Primary outcomes

  1. Change in brain activity, measured through fMRI, following proprioceptive training

    Time frame: Up to 3 months

    Brain activity (BOLD hemodynamic response) will be measured via fMRI before and after proprioceptive training sessions.

  2. Change in spinal cord activity, measured through spinal fMRI, following proprioceptive training

    Time frame: Up to 3 months

    Spinal cord activity (BOLD hemodynamic response) will be measured via spinal fMRI before and after proprioceptive training sessions.

Sponsors and collaborators

Lead sponsor

Direction Centrale du Service de Santé des Armées

Other

Registry information

Official study title

Experimental Study of the Neural Bases of Phantom Pain After Amputation and Their Modification by Proprioceptive Training: MRI Study of the Brain and Spinal Cord

Acronym: Phantom limb

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Sep 19, 2022
Registry last updated
Sep 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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