Clinical trial NCT06702904: Evaluation of Neuroprosthesis with Sensory Feedback for Modulation of Phantom Limb Pain and Enhancing Quality of Life
Official title: Evaluation of Neuroprosthesis with Sensory Feedback for Modulation of Phantom Limb Pain and Enhancing Quality of Life
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
Neurotechnology
Neuroprosthetics
BCI
Lead sponsor: Skolkovo Institute of Science and Technology
Sponsor class: OTHER
Collaborators: name: Motorica LLC
name: The Federal Center of Brain Research and Neurotechnologies
First posted: 2024-11-25
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: SUPPORTIVE_CARE

Brief summary: This clinical trial is designed to assess the effectiveness of advanced neuromodulation techniques in reducing phantom limb pain by improving sensory feedback in bionic prostheses. The study will explore the use of Peripheral Nerve Stimulation to evaluate their impact on pain relief and sensory restoration. The trial aims the development of neuroprostheses that can provide sensory feedback through stimulation.


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: VAS
timeFrame: up to 4 months
measure: SF-36
timeFrame: up to months
measure: DN 4
timeFrame: Up to 6 months
Secondary outcomes:
measure: Sensory threshold change
timeFrame: At least three measurements. 1 - First week after implantation, 2 - Up to three months after implantation, 3 - Up to five months after implantation
measure: Agency
timeFrame: Up to 6 months
measure: Embodiment
timeFrame: Up to 6 months
measure: Pain detect
timeFrame: Up to 6 months
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Up to 6 months
measure: Ownership
timeFrame: Up to 6 months
Other outcomes:
measure: Object detection
timeFrame: Up to 6 months
measure: Visual-motor integration
timeFrame: Up to 4 months
measure: Value of sensory discrimination
timeFrame: Up to once in two weeks
measure: Grasping surface differentiation
timeFrame: Up to 6 months
measure: Sensory discrimination ability
timeFrame: up to 4 months
measure: Clothespin relocation task
timeFrame: Up to 6 months
measure: Fragile objects
timeFrame: Up to 6 months
measure: Sensory feedback in a virtual prosthesis
timeFrame: Up to 6 months
measure: Treadmill
timeFrame: Up to 6 months
measure: Standing Surface Discrimination
timeFrame: Up to 6 months
measure: Staircase test
timeFrame: Up to 6 months
measure: OPUS (Orthotics and Prosthetics User Survey)
timeFrame: Up to 6 months
measure: PEQ (Prosthesis Evaluation Questionnaire)
timeFrame: Up to 6 months
measure: Box and blocks
timeFrame: Up to 6 months
measure: TMS induced muscle potentials
timeFrame: Up to 6 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: Far Eastern Federal University
Study officials:
References: