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

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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

60

단계

  • 해당 없음

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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).

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: tTIS group
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.
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.
다른 이름들:
  • TTIS
가짜 비교기: Sham group
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.
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.
다른 이름들:
  • TTIS

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
visual analogue scale(VAS)
기간: 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)".
Day1(Baseline), day 5 after intervention

2차 결과 측정

결과 측정
측정값 설명
기간
short-form McGill Pain Questionnaire (SF-MPQ)
기간: 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.
Day1(Baseline), day 5 after intervention
Brief Pain Inventory (BPI)
기간: Day1(Baseline), day 5 after intervention
0 = "does not interfere" to 10 = "interferes completely" based on the past 24 hours.
Day1(Baseline), day 5 after intervention
The Patient Global Impression of Change (PGIC)
기간: 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."
Day1(Baseline), day 5 after intervention
17-items of Hamilton Depression Rating Scale (HAMD)
기간: 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
Day1(Baseline), day 5 after intervention
The Beck Depression Inventory-II (BDI-II)
기간: 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).
Day1(Baseline), day 5 after intervention
TIS-EEG: Mean Change From Baseline in Resting-State Posterior Alpha-Band Relative Power at Day 5
기간: 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.
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
기간: 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.
During the 20-minute transcranial temporal interference stimulation session on Day 5

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 8월 1일

기본 완료 (추정된)

2027년 12월 31일

연구 완료 (추정된)

2028년 1월 31일

연구 등록 날짜

최초 제출

2026년 2월 9일

QC 기준을 충족하는 최초 제출

2026년 7월 29일

처음 게시됨 (실제)

2026년 7월 30일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 30일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 29일

마지막으로 확인됨

2026년 1월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • 2025-1132

약물 및 장치 정보, 연구 문서

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이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .