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

NAEnrolling by invitationINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

November 1, 2021

Primary Completion Date

September 1, 2025

Study Completion Date

November 1, 2025

Conditions
Phantom Limb PainPhantom PainAmputation
Interventions
PROCEDURE

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

PNS electrodes are implanted in the area of peripheral nerves of the amputated limb. During phantom pain mapping, multichannel electrodes are used to stimulate peripheral nerves at different sites in the stump. Stimulation turns on sequentially at different stimulation sites; sites are selected where pain is most effectively suppressed. These sites are assigned to the patient for daily modulation.

PROCEDURE

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

SNS electrodes are implanted in the area of targeted peripheral nerves in the amputated limb. During phantom pain mapping, multichannel electrodes are used to stimulate the spinal cord at different sites in the cervical thickening (C5-T1). Stimulation starts at a specific site at a frequency of 1 Hz and increases by 0.1 Hz until the patient no longer feels phantom pain. Stimulation turns on sequentially at different stimulation sites; sites are selected where pain is most effectively suppressed. These sites are assigned to the patient for daily modulation.

PROCEDURE

EEG to search for phantom pain biomarkers

This procedure uses the method of electroencephalography (EEG). EEG signals are recorded during the entire experiment. First, the patient is recorded at rest with stimulator on (PNS/SCS) with eyes open and then closed, in the stimulator off state (eyes open, then closed) when patient's pain returns to its preoperative state. The stimulation is then turned back on to the original level of pain suppression. The moments of pain suppression are fixed by marking.

Trial Locations (1)

690922

Far Eastern Federal University (FEFU), Vladivostok

All Listed Sponsors
lead

Artur Biktimirov

OTHER