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Not yet recruitingNCT05545358Phantom limbUpdated Sep 19, 2022

Neural Bases of Phantom Pain After Amputation

An observational study in Phantom Pain, sponsored by Direction Centrale du Service de Santé des Armées. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-09-19.

Sponsored by Direction Centrale du Service de Santé des Armées · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
75
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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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Conditions studied

  • Phantom Pain

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Keywords

  • fMRI
  • spinal fMRI
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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

The study population is composed of :

  • patients who have been amputated for more than 2 years and have chronic phantom pain;
  • patients who have been amputated for more than 2 years and do not have chronic phantom pain;
  • healthy participants with no neurological history. The patients will be recruited from the cohort of amputee patients followed by the Physical Medicine and Rehabilitation departments of the Hôpital d'Instruction des Armées Laveran, the Hôpital d'Instruction des Armées Desgenettes and the CHU de Saint-Etienne.

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

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
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
75 participants (estimated)
Patient registry
No

Groups and cohorts

  • Amputees with phantom pain

    Adult patients who have been amputated for more than 2 years and have chronic phantom pain

    Other: Questionnaires · Device: Brain and Spinal Cord functional Magnetic Resonance Imaging · Other: Proprioceptive training

  • Amputees without phantom pain

    Adult patients who have been amputated for more than 2 years and do not have chronic phantom pain

    Other: Questionnaires · Device: Brain and Spinal Cord functional Magnetic Resonance Imaging

  • Healthy participants

    Healthy adult participants with no neurological history

    Device: Brain and Spinal Cord functional Magnetic Resonance Imaging · Other: Proprioceptive training

Interventions

  • OtherQuestionnaires

    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)

  • DeviceBrain and Spinal Cord functional Magnetic Resonance Imaging

    Brain and Spinal Cord functional Magnetic Resonance Imaging

  • OtherProprioceptive training

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

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What researchers measure

Primary outcomes

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

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

    Time frame: Up to 3 months

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

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

    Time frame: Up to 3 months

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Study locations

No study locations are listed for this record.

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Registry details

Key details

Study ID
NCT05545358
Lead sponsor
Direction Centrale du Service de Santé des Armées
Responsible party
Sponsor
First posted
Sep 19, 2022
Start date
Oct 2022 (estimated)
Primary completion
Oct 2026 (estimated)
Completion
Oct 2026 (estimated)
Last update
Sep 19, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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