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

Sponsor
Second Affiliated Hospital, Zhejiang University, School of Medicine
Study ID
NCT07735975
Status
Not Yet Recruiting

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Conditions

  • Neuropathic Pain
  • tTIS

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Transcranial temporal interference stimulation — DEVICE
    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.

Study Details

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.

Key Dates

First listed
Jul 30, 2026
Start date
Aug 1, 2026
Status verified
Jan 2026
Primary completion
Dec 31, 2027
Completion
Jan 31, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Sham Comparator: 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.

Primary Outcome Measure

visual analogue scale(VAS) [ Time Frame: Day1(Baseline), day 5 after intervention ]

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