Temporal Interference for Essential Tremor

July 14, 2025 updated by: Liankun_Ren

Efficacy and Safety of Non-invasive Temporal Interference Stimulation in the Treatment of Essential Tremor: A Pilot Trial

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100053
        • Recruiting
        • Xuanwu Hospital, Capital Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Temporal Interference
The investigators perform temporal interference (TI) stimulation to patients with essential tremor. They observe clinical manifestations before and after stimulation to investigate the efficiency of TI.
Other: Temporal Interference
Researchers apply temporal interference (TI) stimulation to the deep brain nuclei of essential tremor patients.
Other Names:
  • TI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tremor Level Evaluation
Time Frame: 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
Up to 3 months after TI stimulation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Liankun_Ren

Investigators

  • Principal Investigator: Liankun Ren, MD, Xuanwu Hospital, Beijing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 9, 2025

Primary Completion (Estimated)

May 30, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

June 3, 2025

First Submitted That Met QC Criteria

June 3, 2025

First Posted (Actual)

June 11, 2025

Study Record Updates

Last Update Posted (Actual)

July 16, 2025

Last Update Submitted That Met QC Criteria

July 14, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-426-002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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