Temporal interference deep brain stimulation for essential tremor
Efficacy and Safety of Non-invasive Temporal Interference Stimulation in the Treatment of Essential Tremor: A Pilot Trial
This study will try temporal interference, a noninvasive form of deep brain stimulation, in people aged 30–70 with essential tremor to see if it reduces their tremor.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 30 Years to 70 Years |
| Sex | All |
| Sponsor | Xuanwu Hospital, Beijing Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT07016425 on ClinicalTrials.gov |
What this trial studies
This is a single-center, prospective study testing temporal interference (TI), a noninvasive method that produces overlapping electric fields to focus stimulation in deep brain nuclei. Eligible participants aged 30–70 with action and postural tremor will receive TI stimulation with clinical and imaging data collected before and after treatment. Clinical scores and imaging will be analyzed to measure changes in tremor severity and brain response. The goal is to determine whether TI can serve as a feasible noninvasive alternative to invasive deep brain stimulation for essential tremor.
Who should consider this trial
Good fit: Ideal candidates are people 30–70 years old with action and postural tremor consistent with essential tremor, who have no major psychiatric or other neurological disorders, can give informed consent, and have no contraindicating implants.
Not a fit: Patients with other neurological diseases (such as epilepsy), moderate to severe cognitive impairment, metal implants, recent electroconvulsive therapy, taking antipsychotic/antidepressant drugs, or significant cardiovascular risk factors may not benefit or be eligible.
Why it matters
Potential benefit: If successful, TI could reduce tremor and improve hand function without the risks of surgical deep brain stimulation.
How similar studies have performed: Temporal interference is a novel, largely preclinical or early proof-of-concept approach with limited prior human data, so clinical success in essential tremor remains unproven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged 30-70 years old, regardless of gender. Action tremor and postural tremor in both upper limbs, or action tremor and postural tremor in one limb; * No history of mental diseases; * Informed consent signed. Exclusion Criteria: * Presence of other neurological diseases affecting the study (such as epilepsy); * Patients with moderate to severe cognitive impairment (Montreal Cognitive Assessment ≤ 18 points); * Orthopedic diseases that may affect motor symptoms; * Patients taking antipsychotic or antidepressant medications; * Presence of metal implants in the body (such as brain pacemakers or cardiac pacemakers); * History of electroconvulsive therapy; * Presence of cardiovascular risk factors, etc.
Where this trial is running
Beijing, Beijing Municipality
- Xuanwu Hospital, Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Liankun Ren, MD — Xuanwu Hospital, Beijing
- Study coordinator: Liankun Ren, MD
- Email: renlk2022@outlook.com
- Phone: +86 13681576621
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.