Effects and Mechanisms of Temporal Interference Stimulation (TIS) on Neuropathic Pain (TIS)
29. juli 2026 oppdatert av: Second Affiliated Hospital, School of Medicine, Zhejiang University
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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
60
Fase
- Ikke aktuelt
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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).
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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.
Andre navn:
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Sham-komparator: 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.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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visual analogue scale(VAS)
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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short-form McGill Pain Questionnaire (SF-MPQ)
Tidsramme: 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.
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Day1(Baseline), day 5 after intervention
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Brief Pain Inventory (BPI)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
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Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. august 2026
Primær fullføring (Antatt)
31. desember 2027
Studiet fullført (Antatt)
31. januar 2028
Datoer for studieregistrering
Først innsendt
9. februar 2026
Først innsendt som oppfylte QC-kriteriene
29. juli 2026
Først lagt ut (Faktiske)
30. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
30. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
29. juli 2026
Sist bekreftet
1. januar 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2025-1132
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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