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NCT Number: NCT07735975

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

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.

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Key information

Conditions

Neuropathic Pain Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms tTIS

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Other names: tTIS

Primary outcomes

  1. visual analogue scale(VAS)

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

    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)".

Secondary outcomes

  1. short-form McGill Pain Questionnaire (SF-MPQ)

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

    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.

  2. Brief Pain Inventory (BPI)

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

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

  3. The Patient Global Impression of Change (PGIC)

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

    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."

  4. 17-items of Hamilton Depression Rating Scale (HAMD)

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

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

  5. The Beck Depression Inventory-II (BDI-II)

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

    BDI-II is a widely used self-report questionnaire designed to assess the severity of depressive symptoms in adults and adolescents.It consists of 21 items, each describing a specific depressive symptom (e.g., sadness, loss of interest, guilt, fatigue, sleep disturbances, appetite changes).

  6. 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

    A 5-minute eyes-closed resting-state electroencephalography recording will be obtained before the first intervention and after the final intervention.

  7. 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

    Electroencephalography will be continuously recorded during the 20-minute transcranial temporal interference stimulation session. After removal of stimulation-related and physiological artifacts using a prespecified preprocessing procedure, alpha-band relative power will be calculated within the 8-13 Hz frequency range and averaged across all included electroencephalography electrodes. Relative alpha power will be calculated as alpha-band power divided by total power within the 1-45 Hz frequency range and multiplied by 100. The within-session change will be calculated as the mean relative alpha power during the final 5 minutes of stimulation minus the mean relative alpha power during the first 5 minutes of stimulation and reported in percentage points.

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Acronym: TIS

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jul 30, 2026
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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