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.
調査の概要
状態
状態
まだ募集していません
条件
条件
介入・治療
介入・治療
研究の種類
研究の種類
介入
入学 (推定)
入学
60
段階
段階
- 適用できない
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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).
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:ダブル
アーム数
2
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
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実験的: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.
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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.
他の名前:
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偽コンパレータ: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.
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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.
他の名前:
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この研究は何を測定していますか?
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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visual analogue scale(VAS)
時間枠:Day1(Baseline), day 5 after intervention
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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)".
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Day1(Baseline), day 5 after intervention
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二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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short-form McGill Pain Questionnaire (SF-MPQ)
時間枠:Day1(Baseline), day 5 after intervention
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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.
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Day1(Baseline), day 5 after intervention
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Brief Pain Inventory (BPI)
時間枠:Day1(Baseline), day 5 after intervention
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0 = "does not interfere" to 10 = "interferes completely" based on the past 24 hours.
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Day1(Baseline), day 5 after intervention
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The Patient Global Impression of Change (PGIC)
時間枠:Day1(Baseline), day 5 after intervention
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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."
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Day1(Baseline), day 5 after intervention
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17-items of Hamilton Depression Rating Scale (HAMD)
時間枠:Day1(Baseline), day 5 after intervention
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The HAMD-17 provides a comprehensive, multi-dimensional snapshot of depression severity, heavily emphasizing sleep, physical (somatic), and anxiety symptoms alongside core mood symptoms
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Day1(Baseline), day 5 after intervention
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The Beck Depression Inventory-II (BDI-II)
時間枠:Day1(Baseline), day 5 after intervention
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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).
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Day1(Baseline), day 5 after intervention
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TIS-EEG: Mean Change From Baseline in Resting-State Posterior Alpha-Band Relative Power at Day 5
時間枠:Day 1 before the first intervention and Day 5 within 30 minutes after completion of the final intervention
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A 5-minute eyes-closed resting-state electroencephalography recording will be obtained before the first intervention and after the final intervention.
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Day 1 before the first intervention and Day 5 within 30 minutes after completion of the final intervention
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Mean Within-Session Change in Alpha-Band Relative Power During Transcranial Temporal Interference Stimulation on Day 5
時間枠:During the 20-minute transcranial temporal interference stimulation session on Day 5
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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.
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During the 20-minute transcranial temporal interference stimulation session on Day 5
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
研究開始
2026年8月1日
一次修了 (推定)
一次修了
2027年12月31日
研究の完了 (推定)
研究の完了
2028年1月31日
試験登録日
最初に提出
最初に提出
2026年2月9日
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
2026年7月29日
最初の投稿 (実際)
最初の投稿
2026年7月30日
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
2026年7月30日
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
2026年7月29日
最終確認日
最終確認日
2026年1月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。