Temporal Interference for Essential Tremor

Not Applicable

Not yet recruiting

• Conditions: Essential Tremor

• Registration Number: NCT07016425
• Lead Sponsor: Liankun_Ren

Brief Summary

This single-center prospective study aims to investigate the treatment efficacy of temporal interference (TI) in essential tremor patients aged 30-70.

Detailed Description

Temporal Interference (TI) technology is a novel non-invasive method for deep brain stimulation (DBS). By generating an overlapping electric field from safe currents, TI creates focused stimulation in targeted deep brain areas. This approach allows for the exploration of deep brain nuclei functions and has the potential to serve as a non-invasive alternative to traditional invasive DBS for clinical treatments.

This study aims to investigate the treatment efficacy of TI deep brain stimulation by including essential tremor patients aged 30-70. Before and after TI stimulation, clinical data will be recorded. Clinical and imaging data will be analyzed and processed to advance the treatment of essential tremor.

Study Timeline

• Status Verified: 2025-06
• Study Start: 2025-06-01
• Study First Submitted: 2025-06-03
• Study First Submitted QC: 2025-06-03
• Last Update Submitted: 2025-06-03
• Study First Posted: 2025-06-11
• Last Update Posted: 2025-06-11
• Primary Completion: 2026-05-30
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Tremor Level Evaluation	Up to 3 months after TI stimulation	Percentage change in per month after stimulation from baseline in The Essential Tremor Rating Assessment Scale(TETRAS) score. The TETRAS score ranges from 0 to 112, including an activities of daily living (ADL) section(0-48 scores) and a performance section(0-64 scores), with higher scores representing more severe tremor and lower scores indicating lower tremor level

Trial Locations

Locations (1)

Xuanwu Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China