Evaluation of Neuroprosthesis with Sensory Feedback for Modulation of Phantom Limb Pain and Enhancing Quality of Life

Not Applicable

Recruiting

• Conditions: Phantom Limb Pain

• Registration Number: NCT06702904
• Lead Sponsor: Skolkovo Institute of Science and Technology

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-13
• Study First Submitted QC: 2024-11-21
• Last Update Submitted: 2024-11-21
• Study First Posted: 2024-11-25
• Last Update Posted: 2024-11-25
• Study Start: 2024-12-01
• Primary Completion: 2028-09-01
• Study Completion: 2029-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
VAS	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	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	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 Outcome Measures

Name	Time	Method
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	In this task, the minimal amplitude of stimulation required to evoke a sensory response is experimentally determined. Numbers 1 and 2 appear on the screen, and at the moment one of the numbers appears, stimulation is simultaneously activated. The participant's task is to identify when the stimulation occurred and to input their response using the keyboard. After completing the task, a psychophysical curve will be computed, and the amplitude value that yields an accuracy of 0.75 will be used.
Agency	Up to 6 months	Self-report questionnaires where participants rate their sense of agency over the prosthesis during tasks. It uses 0 to 10 scale, where 0 means lower agency and 10 means higher agency
Pain detect	Up to 6 months	The questionnaire is intended for completion by a physician and combines a pain distribution diagram with a visual analog scale (VAS) and a section focused on identifying spontaneous and triggered neuropathic pain symptoms. It also assesses the nature of pain using the diagram, categorizing it as constant, episodic, or constant with episodes, among others. The questionnaire comprehensively reflects all possible pain parameters, allowing for clear tracking of pain dynamics over time.; The total score ranges from -1 to 38. Based on this score: ≤ 12: Neuropathic pain is unlikely. 13-18: The result is ambiguous; further assessment may be needed.; ≥ 19: Neuropathic pain is likely.
Embodiment	Up to 6 months	Throughout the study, participants will be asked to complete questionnaires assessing the degree of embodiment of the prosthesis. Since during the experimental sessions, feedback from the prosthesis is projected onto the phantom limb, the research team anticipates observing a transfer effect from the phantom limb to the robotic hand. The degree of this transfer will be evaluated using the Embodiment questionnaires for both upper and lower limbs.; Embodiment uses scale from -9 to 9; -9 means "No embodiment" and 9 means "High embodiment".
Hospital Anxiety and Depression Scale (HADS)	Up to 6 months	The Hospital Anxiety and Depression Scale (HADS) is a widely used screening tool designed to assess anxiety and depression levels in patients in non-psychiatric hospital settings. It consists of 14 items, divided into two subscales: seven questions assess anxiety (HADS-A) and seven assess depression (HADS-D). The items focus on emotional and cognitive symptoms rather than physical symptoms, making it suitable for patients with medical conditions. Each item is scored on a scale of 0 to 3, with total scores for each subscale ranging from 0 to 21. A score of 8 or more on either subscale suggests the presence of anxiety or depression. The HADS is valued for its simplicity and reliability in clinical and research settings.
Ownership	Up to 6 months	Self-report questionnaires where participants rate their sense of ownership over the prosthesis during tasks. It uses 0 to 10 scale, where 0 means lower agency and 10 means higher agency

Trial Locations

Locations (2)

Federal Center of Brain Research and Neurotechnologies of the Federal Medical Biological Agency of Russia; 🇷🇺 Moscow, Russian Federation

Far Eastern Federal University; 🇷🇺 Moscow, Russian Federation