Effects and Mechanisms of Temporal Interference Stimulation (TIS) on Neuropathic Pain | NCT07735975

NCT07735975

Overview

NCT ID: NCT07735975
Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang UniversityOTHER
Official Title: Effects and Mechanisms of Temporal Interference Stimulation (TIS) on Neuropathic Pain
Brief Summary: This study employs temporal interference stimulation (tTIS) to investigate the analgesic effects of tTIS on neuropathic pain and monitor changes in neural plasticity, and explore the dynamic relationship between analgesic efficacy and neural plasticity, thereby providing new strategies for the treatment of neuropathic pain.
Conditions: Neuropathic Pain
tTIS
Interventions: Transcranial temporal interference stimulation

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 30, 2026Actual
Start Date: Aug 1, 2026Estimated
Primary Completion Date: Dec 31, 2027Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

IASP diagnosis of peripheral neuropathic pain;

At least one month after the onset of pain;

At least moderate pain intensity (≥ 3 assessed by VAS or NRS);

18 years or older;

Stable medical treatment from 2 weeks before allocation to the end of the trial;

Willing to receive TIS treatment and capable of fulfilling clinical assessments.

Exclusion Criteria:

Contradictions to TIS treatment, such as metal implants or seizure;

Serious psychiatric disorder (Hamilton Depression Rating Scale score ≥ 35 or Hamilton Anxiety Rating Scale score ≥ 29);

Aphasia or cognitive disorders (Mini mental state examination ≤ 24);

Severe clinical disorders caused by tumor or other conditions;

Severe cardiopulmonary dysfunction or extreme weakness;

History of substance abuse (alcohol, drugs).

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 60Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

Contacts and Locations

Central Contacts: No data available
Locations: No data available

Similar Studies

Participant Group/Arms

tTIS groupExperimental

Following enrollment, patients underwent TIS treatment administered twice daily over five consecutive days, for a total of ten sessions. The stimulation was targeted at the periaqueductal gray (PAG) region contralateral to the side of pain. Assessments were conducted before treatment (T0) and immediately after the treatment course (T1), evaluating pain perception, emotional changes, and quality of life. Additionally, local and whole-brain mechanisms were examined using TIS-EEG and fMRI.

Device: Transcranial temporal interference stimulation

Sham groupSham Comparator

The sham group followed the same procedure as the TIS group. However, the electrical current was only delivered in a 30-second ramp-up at the beginning and a 30-second ramp-down at the end of each session to replicate the initial peripheral sensation without providing sustained therapeutic stimulation.

Device: Transcranial temporal interference stimulation