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RECRUITING
NCT07359677
NA

High-frequency Alternating Current Stimulation for Neurophatic Pain in Spinal Cord Injury

Sponsor: University of Castilla-La Mancha

View on ClinicalTrials.gov

Summary

To investigate the safety and effectiveness of transcutaneous electrical stimulation with 40 kHz alternating currents combined with standard treatment compared to placebo electrical stimulation plus standard treatment for neuropathic pain in people with spinal cord injury.

Official title: Effectiveness and Safety of Transcutaneous Electrical Stimulation With 40 kHz Alternating Currents in People With Spinal Cord Injury and Neuropathic Pain. A Randomised, Double-blind, Parallel Pilot Study With Placebo Control

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2026-01-30

Completion Date

2026-03-31

Last Updated

2026-02-25

Healthy Volunteers

No

Interventions

DEVICE

Active group 40 kHz

For experimental electrical stimulation, two stainless steel electrodes with conductive gel will be applied over the bilateral spinal roots with a separation between electrodes of at least 2 cm and a distance between the medial edge of each electrode and the spinous process of at least 1 cm. The upper third of the electrode will be placed above the level of spinal cord injury where the participant will have preserved sensitivity, and the remaining two thirds in the lesion and/or infralesional area. An unmodulated rectangular alternating or biphasic electrical current with a frequency of 40 kHz will be applied. The intensity of the current will be adjusted individually, increasing it until the participant reports a sensation of 'strong but comfortable tingling' just below the motor threshold. Every two minutes, the intensity of the current will be adjusted if the tingling sensation decreases. The electrical current will be applied for 20 minutes in two 10-minute phases.

DEVICE

Sham intervention

Placebo stimulation will be performed using the same electrical current device, the same electrode placement, and the same stimulation parameters as in the experimental stimulation, but the current intensity will be increased only during the initial 30 initial seconds and the final 30 seconds of the session, with the current intensity set to 0 mA for the rest of the intervention (20 minutes).

Locations (1)

Hospital Nacional de Parapléjicos

Toledo, Spain