Study of Phantom Limb Pain Using Peripheral Nerve and Spinal Cord Stimulation

Artur Biktimirov

Status

Invitation-only

Conditions

Amputation

Phantom Pain

Phantom Limb Pain

Treatments

Procedure: Implantation of PNS electrodes during surgery, mapping to select sites with the best effect and pain modulation.

Procedure: SCS electrode implantation at surgery, mapping to select sites with the best effect and pain modulation.

Procedure: EEG to search for phantom pain biomarkers

Study type

Interventional

Funder types

Other

Identifiers

NCT05650931

DVFU-09

Details and patient eligibility

About

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 (SCS) stimulation with implantable electrodes. The researchers expect that PLP in patients with upper limb amputation will be relieved by peripheral nerve and the spinal cord stimulation. The possibility of finding EEG biomarkers for phantom pain will be explored.

Full description

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 upper limb. Neuromodulation is a potential treatment option for chronic pain that may alter maladaptive neuroplasticity and enhance descending inhibitory pathways.

Study participants will be selected according to the inclusion criteria. Next, multichannel electrodes will be implanted in the region of the target peripheral nerves of the amputated limb and the corresponding segments of the spinal cord. The evaluation of the therapeutic effects of pain syndromes will be carried out in the mode of long-term repetitive nerve stimulation. Postoperative follow-up will be carried out from 2 weeks to 1 month. During the follow-up period, patients will complete scales and questionnaires daily.

The stimulator is turned on the day after surgery to assess pain relief. The patient is explained the rules for using the stimulator. The selection of stimulation parameters is carried out according to the generally accepted methodology (the stimulation zone should overlap the pain zone; stimulation should be in the nature of pleasant vibrations). The patient will be given a test stimulation diary to complete every day (at the end of the day) during the entire stimulation period.

The researchers expect that phantom limb pain in patients undergoing upper limb amputation will be relieved by peripheral nerve stimulation. We will explore the possibility of creating a personal phantom sensitivity map to optimize the stimulation program. We will study improving the quality of life and reducing pain.

Patients will be asked to participate in an experiment using electroencephalography (EEG) starting on the 3rd day after implantation. The purpose of this entry is to investigate the bimarkers of phantom pain. As part of the experimental procedure, we plan to sequentially turn off the stimulator until the patient returns to the preoperative pain state, and also turn on the stimulator with fixation of the moments of pain suppression to the level at the beginning of the experiment. During the entire period, the patient's EEG will be recorded. The researchers expect to see changes in alpha and theta EEG rhythms under these experimental conditions.

Enrollment

10 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with implanted neuromodulation devices.
Amputation of the upper limb at the level of the forearm.
Age ranges from 18 to 65 years old.
The duration from the moment of amputation is from 6 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
The presence of mental illness
The presence of a gross orthopedic deformity in the limb above the amputation level.
The presence of oncology.
The presence of epilepsy.
Complications after a traumatic brain injury or stroke.
Purulent - septic pathology.
Drug addiction.
Congenital malformation of the upper limb.
Any conditions that, according to the researcher, fall under the exclusion criteria.