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

NCT07735975 | Not Yet Recruiting DMC

• 1 other identifier: 2025-1132
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• visual analogue scale(VAS)

  It typically consists of a 10-centimeter straight line, with two endpoints representing extreme states of the measured experience. For example, when assessing pain, one end is labeled "0 (no pain at all)" and the other end "10 (worst pain imaginable, unbearable)".

  Day1(Baseline), day 5 after intervention

Secondary Outcomes (7)

• short-form McGill Pain Questionnaire (SF-MPQ)

  Day1(Baseline), day 5 after intervention

• Brief Pain Inventory (BPI)

  Day1(Baseline), day 5 after intervention

• The Patient Global Impression of Change (PGIC)

  Day1(Baseline), day 5 after intervention

• 17-items of Hamilton Depression Rating Scale (HAMD)

  Day1(Baseline), day 5 after intervention

• The Beck Depression Inventory-II (BDI-II)

  Day1(Baseline), day 5 after intervention

Study Arms (2)

tTIS group

EXPERIMENTAL

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 group

SHAM 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

Interventions

Transcranial temporal interference stimulation DEVICE

tTIS was applied to the PAG contralateral to the pain side for a duration of 20 minutes, comprising a 30-second ramp-up phase and a 30-second ramp-down phase.

Also known as: tTIS

Sham group; tTIS group

Eligibility Criteria

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

You may qualify if:

• 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);
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

MeSH Terms

Conditions

Neuralgia

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: July 30, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): January 31, 2028
• Last Updated: July 30, 2026

Record last verified: 2026-01