Evaluation of Neuroprosthesis with Sensory Feedback for Modulation of Phantom Limb Pain and Enhancing Quality of Life
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Phantom Limb Pain
- Sponsor
- Skolkovo Institute of Science and Technology
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- VAS
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
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.
Outcomes
Primary Outcomes
VAS
Time Frame: up to 4 months
The Visual Analog Scale (VAS) is a 10 cm line used to measure pain intensity. One end of the line represents \"no pain,\" while the other end signifies \"worst possible pain.\" The line can be either horizontal or vertical.
DN 4
Time Frame: Up to 6 months
The DN4 (Douleur Neuropathique 4) questionnaire is a diagnostic tool designed to identify neuropathic pain, caused by nerve damage. It includes 10 items divided into two sections. The first part consists of seven questions that assess the patient's pain symptoms, such as burning, tingling, electric shocks, or numbness. The second part involves a clinical examination where the physician tests for reduced sensitivity to touch and pinprick, as well as pain response to light brushing. Each item is scored with 1 point for "Yes" and 0 for "No." A total score of 4 or higher indicates a high probability of neuropathic pain.
SF-36
Time Frame: up to months
The questionnaire consists of 36 items grouped into eight scales: physical functioning, role limitations due to physical health, bodily pain, general health, vitality, social functioning, emotional well-being, and mental health. Each scale ranges from 0 to 100, where 100 represents full health. Higher scores indicate better quality of life, with two summary measures: physical and mental well-being.
Secondary Outcomes
- Sensory threshold change(At least three measurements. 1 - First week after implantation, 2 - Up to three months after implantation, 3 - Up to five months after implantation)
- Agency(Up to 6 months)
- Pain detect(Up to 6 months)
- Embodiment(Up to 6 months)
- Hospital Anxiety and Depression Scale (HADS)(Up to 6 months)
- Ownership(Up to 6 months)