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

NCT07359677 | Completed

• 1 other identifier: SCI-Neuromodest-gifto
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neuropathic Pain; Spinal Cord Injuries (SCI)

Keywords

High-frequency alternating current stimulation; Spinal cord injury; Neuropathic pain

Outcome Measures

Primary Outcomes (1)

• Pain perception - NPSI

  It will be assessed using the Spanish version of the Neuropathic Pain Symptom Inventory (NPSI), and the result will be taken as the change from baseline at different time points. This questionnaire has a score ranging from 0 to 100 points, with a higher score indicating greater severity of neuropathic pain symptoms. Regarding the psychometric properties of this questionnaire, it has been shown that the areas under the receiver operating characteristic curves were greater than 0.85 and all reliability coefficients were greater than 0.70.

  Prior to the intervention (Baseline), during the intervention after five sessions (Day 5), after the intervention (Day 10) and one week after the end of the intervention (Day 15)

Secondary Outcomes (9)

• Pain perception - VAS

  Baseline (-5 to 0 days), week 1 treatment (days 1-5), week 2 treatment (days 6-10) and post-treatment week (days 11-15).

• Change in pain threshold evoked by mechanical stimuli

  Prior to the intervention (Baseline), during the intervention after five sessions (Day 5), after the intervention (Day 10) and one week after the end of the intervention (Day 15)

• Change in pain threshold evoked by thermal (cold and heat) stimuli

  Prior to the intervention (Baseline), during the intervention after five sessions (Day 5), after the intervention (Day 10) and one week after the end of the intervention (Day 15)

• Patient's Overall Impression of Change

  During the intervention after five sessions (Day 5), after the intervention (Day 10) and one week after the end of the intervention (Day 15)

• Percentage of participants responding to treatment

  Baseline (-5 to 0 days), week 1 treatment (days 1-5), week 2 treatment (days 6-10) and post-treatment week (days 11-15).

Other Outcomes (1)

• Success of blinding

  Day 10

Study Arms (2)

Experimental: 40 kHz

EXPERIMENTAL

Alternating current stimulation with a 40kHz frequency with a transcutaneous approach, 20 minutes for each intervention.

Device: Active group 40 kHz

Sham stimulation

SHAM COMPARATOR

Sham stimulation via transcutaneous approach will be delivered only for the first 30 seconds, following the same procedures as the 40kHz group.

Device: Sham intervention

Interventions

Active group 40 kHz DEVICE

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.

Experimental: 40 kHz

Sham intervention DEVICE

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).

Sham stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• People with spinal cord injuries of any aetiology affecting the D1 spinal cord level or lower (paraplegia)
• With injury grade A, B, C, or D according to the ASIA (American Spinal Injury Association) Impairment Scale (AIS)
• Time since spinal cord injury ≥ 3 months
• A score of ≥ 4 points on the Dolour Neuropathique 4 (DN4) scale
• Neuropathic pain at the level of the injury (within the dermatome at that level and up to three dermatomes below) and/or below the level of the injury (more than three dermatomes below)
• Duration of pain ≥ 1 month
• Average pain perception score ≥ 30 mm on the visual analogue scale (VAS) in the week prior to eligibility, with a daily record of 5 days (Monday to Friday) in the morning.
• Be able to understand instructions and assessment tools
• Agree to participate in the study and sign the informed consent form

You may not qualify if:

• Cauda equina injuries
• Brain injuries or other central nervous system injuries concomitant with spinal cord injury
• A value of 100 mm in any of the daily records collected in the week prior to eligibility
• Having any contraindications for the application of transcutaneous electrical stimulation: cardiac pacemaker or any other implanted electrical device, epilepsy, pregnancy, active malignant tumours in the area of application of the stimulation, and wounds or skin damage in the area of stimulation
• History of psychiatric illness
• Major depression
• Spinal cord injury caused by autolysis
• Changes in medication prescribed for the treatment of pain and spasticity during the study
• Acute nociceptive pain in any area of the body during the study

Sponsors & Collaborators

• University of Castilla-La Mancha: lead
• Hospital Nacional de Parapléjicos de Toledo: collaborator

Study Sites (1)

Hospital Nacional de Parapléjicos

Toledo, 45005, Spain

Location

MeSH Terms

Conditions

Neuralgia; Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Juan Avendaño-Coy, PhD

  Castilla La Mancha University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Blinding of participants will be performed using the same equipment, electrodes, and placement for the real or sham stimulation treatments. In addition, both the participants and the outcome assessor will not have a view of the equipment screen. Blinding of the outcome assessor will be performed using different team members for randomization of the interventions (Researcher 1), intervention (Researcher 2), evaluation (Researcher 3), and statistical analysis (Researcher 4). Randomization will be kept hidden from participants and research team members and only the researcher who will deliver the intervention (Researcher 2) will know the group assignment. Successful blinding of participants and evaluator will be analyzed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two interventions will be performed: * Intervention A: active stimulation (High-frequency current stimulation 40kHz). * Intervention B: sham stimulation (simulated electrical stimulation).

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: January 22, 2026
• Study Start: January 30, 2026
• Primary Completion: April 7, 2026
• Study Completion: April 7, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)