Study of Phantom Limb Pain Suppression Using Neuromodulation Methods

Not Applicable

Recruiting

• Conditions: Phantom Limb Pain

• Registration Number: NCT06644807
• Lead Sponsor: Skolkovo Institute of Science and Technology

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-09-01
• Study First Submitted: 2024-09-02
• Status Verified: 2024-10
• Study First Submitted QC: 2024-10-14
• Last Update Submitted: 2024-10-14
• Study First Posted: 2024-10-16
• Last Update Posted: 2024-10-16
• 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
Visual analogue scale (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.
SF-36	up to 1 year	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 mapping	up to 4 months	The sensory mapping procedure involved evoking sensations in phantom hands through peripheral nerve stimulation (PNS). Electrode pairs were selected, and stimulation parameters, with fixed pulse width and frequency were applied. Stimulation amplitude was gradually increased in 0.1-mA steps until participants rated their sensation intensity from 0 (no sensation) to 10 (uncomfortably intense). Upon reaching a score of 5, participants marked sensation location on a hand image and described the sensation's naturalness and intensity.
Pain detect	Up 1 year	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. Its diagnostic accuracy is 83%.
DN 4	up to 1 year	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.
Hospital Anxiety and Depression Scale, HADS	up to 1 year	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.
Sensory threshold	up to 6 months	In this experiment, the goal is to determine the minimum stimulation amplitude that elicits a sensory response. Participants are shown the numbers 1 and 2 on a screen, with stimulation activated simultaneously upon the appearance of one of the numbers. Their task is to identify when the stimulation occurred and input their answer on a keyboard. An expanded version of the experiment may provide stimulation during both moments, requiring participants to determine which moment had a higher stimulation level. The results will yield a psychophysical curve that illustrates the relationship between response accuracy and stimulation amplitude, as well as the participants' ability to differentiate stimulation parameters. It is anticipated that over time, the sensory threshold will shift, leading to increased accuracy in parameter identification.

Trial Locations

Locations (1)

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