About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Parallel
Treatments tested in this trial
Transcranial temporal interference stimulation
DevicetTIS 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.
Treatment groups
Trial outcomes
Primary outcomes
visual analogue scale(VAS)
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
short-form McGill Pain Questionnaire (SF-MPQ)
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)
0 = "does not interfere" to 10 = "interferes completely" based on the past 24 hours.
The Patient Global Impression of Change (PGIC)
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)
The HAMD-17 provides a comprehensive, multi-dimensional snapshot of depression severity, heavily emphasizing sleep, physical (somatic), and anxiety symptoms alongside core mood symptoms
Locations
Sponsors and contacts
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