NCT07016425

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
5mo left

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress70%
Jun 2025Sep 2026

First Submitted

Initial submission to the registry

June 3, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

June 9, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 11, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

July 16, 2025

Status Verified

July 1, 2025

Enrollment Period

12 months

First QC Date

June 3, 2025

Last Update Submit

July 14, 2025

Conditions

Essential Tremor

Keywords

Temporal InterferenceEssential Tremor

Outcome Measures

Primary Outcomes (1)

  • Tremor Level Evaluation

    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

Study Arms (1)

Temporal Interference

EXPERIMENTAL

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

Interventions

Temporal InterferenceOTHER

Researchers apply temporal interference (TI) stimulation to the deep brain nuclei of essential tremor patients.

Temporal Interference

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100053, China

RECRUITING

MeSH Terms

Conditions

Essential Tremor

Condition Hierarchy (Ancestors)

Movement DisordersCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Liankun Ren, MD

    Xuanwu Hospital, Beijing

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Liankun Ren, MD

CONTACT

+86 13681576621renlk2022@outlook.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 3, 2025

First Posted

June 11, 2025

Study Start

June 9, 2025

Primary Completion (Estimated)

May 30, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

July 16, 2025

Record last verified: 2025-07

Locations

CN(1)