Clinical trial NCT06644807: Study of Phantom Limb Pain Suppression Using Neuromodulation Methods
Official title: Neuromodulation Methods for Suppressing Phantom Limb Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Phantom Limb Pain
Keywords: Neuromodulation
Phantom limb pain
Neuropathic pain
Neurostimulation
Chronic pain
Peripheral nerve stimulation
PNS
Spinal cord stimulation
SCS
Dorsal root ganglion stimulation
DRG
Cortical stimulation
Amputation
Amputees
Upper-limb injury
Lead sponsor: Skolkovo Institute of Science and Technology
Sponsor class: OTHER
Collaborators: name: Motorica LLC
name: Federal center of brain research and neurotechnologies
First posted: 2024-10-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study assesses the effectiveness of neuromodulation in alleviating pain through the stimulation of peripheral nerves. The research involves implanting electrodes for test stimulation of peripheral nerves (PNS - Peripheral Nerve Stimulation), spinal cord (SCS - Spinal Cord Stimulation), dorsal root ganglia (DRGS - Dorsal Root Ganglion Stimulation), and motor cortex (MCS - Motor Cortex Stimulation). The study aims to explore the use of neuromodulation for pain relief in patients experiencing pain due to upper or lower limb amputation.


Eligibility criteria: Inclusion Criteria:

* Amputation of the upper limb at the level of the forearm or upper arm, or amputation of the lower limb at the level of the lower leg or thigh.
* Age between 18 and 65 years.
* Duration since amputation is at least 6 months.
* Presence of persistent chronic pain syndrome rated between 4 and 10 on the Visual Analog Scale (VAS).
* Absence of pregnancy at the time of implantation, confirmed by a pregnancy test (for female participants only).
* Signed consent to participate in the study.

Exclusion Criteria:

* Presence of severe somatic pathology that hinders surgical treatment and participation in the study.
* Presence of psychiatric disorders (including a history of), severe depression, suicidal tendencies, or a history of suicide attempts.
* Presence of severe orthopedic deformity in the limb above the level of amputation.
* History of cancer.
* History of epilepsy.
* Complicated traumatic brain injury (TBI) or a history of stroke.
* Inability to undergo electrostimulation due to other somatic pathology.
* Purulent-septic pathology.
* Drug addiction (including a history of).
* Congenital anomaly of upper limb development.
* Anomalies in the development of the central and peripheral nervous systems.

Primary outcomes:
measure: Visual analogue scale (VAS)
timeFrame: Up to 4 months
measure: SF-36
timeFrame: up to 1 year
Secondary outcomes:
measure: Sensory mapping
timeFrame: up to 4 months
measure: Pain detect
timeFrame: Up 1 year
measure: DN 4
timeFrame: up to 1 year
measure: Hospital Anxiety and Depression Scale, HADS
timeFrame: up to 1 year
measure: Sensory threshold
timeFrame: up to 6 months
Other outcomes:
measure: OPUS
timeFrame: up to 4 months
measure: PEQ (Prosthesis Evaluation Questionnaire)
timeFrame: up to 4 months
Locations:
city: Moscow
country: Russian Federation
facility: Federal Center of Brain Research and Neurotechnologies of the Federal Medical Biological Agency of Russia
city: Moscow
country: Russian Federation
facility: Federal Center of Brain Research and Neurotechnologies of the Federal Medical Biological Agency of Russia
Study officials:
References: