Neural Bases of Phantom Pain After Amputation

Phantom Pain Clinical Trial

— Phantom limb  

Official 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05545358
• Other study ID #: 2020PPRC09
• Secondary ID: 2021-A01733-38
• Status: Not yet recruiting
• Start date: October 2022
• Est. completion date: October 2026

Study information

• Verified date: September 2022
• Source: Direction Centrale du Service de Santé des Armées
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 75
• Est. completion date: October 2026
• Est. primary completion date: October 2026
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Phantom Limb
• Phantom Pain

Intervention

Other:
• Questionnaires
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)

Device:
• Brain and Spinal Cord functional Magnetic Resonance Imaging
Brain and Spinal Cord functional Magnetic Resonance Imaging

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Direction Centrale du Service de Santé des Armées

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 3 months
Primary	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.	Up to 3 months