Neuropathic Pain, tTIS
Conditions
Brief summary
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
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.
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| visual analogue scale(VAS) | 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
| Measure | Time frame | Description |
|---|---|---|
| short-form McGill Pain Questionnaire (SF-MPQ) | 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. |
| Brief Pain Inventory (BPI) | Day1(Baseline), day 5 after intervention | 0 = "does not interfere" to 10 = "interferes completely" based on the past 24 hours. |
| The Patient Global Impression of Change (PGIC) | 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." |
| 17-items of Hamilton Depression Rating Scale (HAMD) | 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 |
| The Beck Depression Inventory-II (BDI-II) | 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). |
| TIS-EEG: Mean Change From Baseline in Resting-State Posterior Alpha-Band Relative Power at Day 5 | 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. |
| Mean Within-Session Change in Alpha-Band Relative Power During Transcranial Temporal Interference Stimulation on Day 5 | 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. |
Outcome results
None listed