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Not yet recruiting NCT07735975

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

No phase Interventional Neuropathic Pain tTIS

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transcranial temporal interference stimulation.
Who it may be relevant to
Registry conditions: Neuropathic Pain, tTIS. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Device Transcranial temporal interference stimulation
    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.

Primary outcome measures

  • visual analogue scale(VAS) [Time frame: Day1(Baseline), day 5 after intervention]
Secondary outcome measures (7)
  • short-form McGill Pain Questionnaire (SF-MPQ) [Time frame: Day1(Baseline), day 5 after intervention]
  • Brief Pain Inventory (BPI) [Time frame: Day1(Baseline), day 5 after intervention]
  • The Patient Global Impression of Change (PGIC) [Time frame: Day1(Baseline), day 5 after intervention]
  • 17-items of Hamilton Depression Rating Scale (HAMD) [Time frame: Day1(Baseline), day 5 after intervention]
  • The Beck Depression Inventory-II (BDI-II) [Time frame: Day1(Baseline), day 5 after intervention]
  • TIS-EEG: Mean Change From Baseline in Resting-State Posterior Alpha-Band Relative Power at Day 5 [Time frame: Day 1 before the first intervention and Day 5 within 30 minutes after completion of the final intervention]
  • Mean Within-Session Change in Alpha-Band Relative Power During Transcranial Temporal Interference Stimulation on Day 5 [Time frame: During the 20-minute transcranial temporal interference stimulation session on Day 5]

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07735975 · 2025-1132

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗