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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: tTIS groupExperimental treatment 1 intervention
Group B: Sham groupSham comparator 1 intervention

Trial outcomes

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)".

Time frame
Day1(Baseline), day 5 after intervention

Secondary outcomes

1

short-form McGill Pain Questionnaire (SF-MPQ)

The Pain Rating Index of the Short-Form McGill Pain Questionnaire consists of 15 pain descriptors, including 11 sensory descriptors and 4 affective descriptors. Each item is rated from 0 (none) to 3 (severe). Item scores are summed to produce a total score ranging from 0 to 45, with higher scores indicating greater pain severity. The outcome measure is the change in the total Pain Rating Index score from baseline to Day 5 after intervention.

Time frame
Day1(Baseline), day 5 after intervention
2

Brief Pain Inventory (BPI)

0 = "does not interfere" to 10 = "interferes completely" based on the past 24 hours.

Time frame
Day1(Baseline), day 5 after intervention
3

The Patient Global Impression of Change (PGIC)

Single-item structure: It consists of a single question that asks patients to rate how much their condition has changed since a specified baseline.2.7-point response scale: Responses range from "very much improved" (score 1) to "very much worse" (score 7), with intermediate options including "much improved," "minimally improved," "no change," "minimally worse," and "much worse."

Time frame
Day1(Baseline), day 5 after intervention
4

17-items of Hamilton Depression Rating Scale (HAMD)

The HAMD-17 provides a comprehensive, multi-dimensional snapshot of depression severity, heavily emphasizing sleep, physical (somatic), and anxiety symptoms alongside core mood symptoms

Time frame
Day1(Baseline), day 5 after intervention

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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