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Search / Trial NCT05807607

Study of Lower-limb Phantom Pain Syndrome Using Peripheral Nerve and Spinal Cord Stimulation

Launched by ARTUR BIKTIMIROV · Mar 29, 2023

Trial Information

Current as of June 26, 2025

Enrolling by invitation

Keywords

Neurostimulation Spinal Cord Stimulation Peripheral Nerve Stimulation Phantom Limb Pain Pain Suppression Lower Limb Amputation

ClinConnect Summary

The purpose of this study is to evaluate the effectiveness of neuromodulation for relief of phantom limb pain (PLP) using peripheral nerve (PNS) and spinal cord stimulation (SCS) with implantable electrodes.

The study is conducted to collect information on the role of non-adaptive neuroplasticity and inhibitory descending antinociceptive influences, which determine the effect of peripheral nerve and spinal cord stimulation with implanted electrodes in patients with phantom limb pain as a result of amputation of the lower limb. Neuromodulation is a potential treatment option for chronic pai...

Gender

ALL

Eligibility criteria

  • Inclusion criteria for the study:
  • Patients with implanted neuromodulation devices.
  • Amputation of the lower limb.
  • Age ranges from 18 to 65 years old.
  • The duration from the moment of amputation is from 12 months.
  • The presence of persistent chronic pain syndrome is from 4 to 10 points according to the Visual Analogue Scale
  • Absence of pregnancy at the time of implantation, confirmed by a pregnancy test.
  • Exclusion criteria:
  • The presence of severe somatic pathology that prevents surgical treatment and participation in the study.
  • The presence of mental illness (including history), severe depression, suicidal tendencies, history of suicide.
  • The presence of gross orthopedic deformity in the limb above the amputation level.
  • History of oncology.
  • History of epilepsy.
  • Complicated TBI or history of stroke.
  • The impossibility of conducting electrical stimulation due to another somatic pathology.
  • Purulent septic pathology.
  • Drug addiction (including history).
  • Congenital malformation of the lower limb.
  • Anomalies in the development of the CNS.
  • Any conditions that fall under the exclusion criteria according to the researchers.

About Artur Biktimirov

Artur Biktimirov is a dedicated clinical trial sponsor with a commitment to advancing medical research and improving patient outcomes. With a robust background in clinical development and a focus on innovative therapeutic solutions, Mr. Biktimirov leads initiatives that adhere to the highest standards of regulatory compliance and ethical practice. His expertise encompasses a wide range of therapeutic areas, reflecting a deep understanding of the complexities involved in clinical trials. Through strategic collaboration and a patient-centered approach, he aims to contribute significantly to the advancement of healthcare and the discovery of new treatment modalities.

Locations

Vladivostok, Primorsky Krai, Russian Federation

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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