NCT06145932

Brief Summary

The purpose of this study is to evaluate the efficacy and electrophysiology of repetitive transcranial magnetic stimulation in the treatment of essential tremor.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started Nov 2023

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Nov 2023Dec 2026

Study Start

First participant enrolled

November 7, 2023

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

November 12, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 24, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

November 24, 2023

Status Verified

November 1, 2023

Enrollment Period

3 years

First QC Date

November 12, 2023

Last Update Submit

November 16, 2023

Conditions

Essential Tremor

Keywords

Essential TremorTranscranial magnetic stimulation

Outcome Measures

Primary Outcomes (2)

  • The efficacy of the treatment on the essential tremor evaluated by Essential Tremor Rating Assessment Scale (TETRAS) score

    The TETRAS is widely used tremor evaluation scale.TETRAS has been used for evaluation tremor in patients with essential tremor focuses primarily on the assessment of activities of daily living and tremor.The TETRAS score ranges from 0 to 112. The higher the TETRAS score, the more severe the symptoms.

    visit 1(baseline), visit 2(Day 10), visit 3(Day 30)

  • Changes from baseline in tremor analysis

    This outcome reflects quantitative changes in the patient's tremor.

    visit 1(baseline), visit 2(Day 10), visit 3(Day 30)

Secondary Outcomes (13)

  • Changes from baseline in TMS-EEG

    visit 1(baseline), visit 2(Day 10), visit 3(Day 30)

  • Change in Non-Motor Symptoms Rating Scale (NMSS) score from baseline

    visit 1(baseline), visit 2(Day 10), visit 3(Day 30)

  • Change in Mini-Mental State Examination (MMSE) score from baseline

    visit 1(baseline), visit 2(Day 10), visit 3(Day 30)

  • Change in Montreal Cognitive Assessment (MOCA) score from baseline

    visit 1(baseline), visit 2(Day 10), visit 3(Day 30)

  • Changes from baseline in Hamilton Anxiety Scale(HAMA) score

    visit 1(baseline), visit 2(Day 10), visit 3(Day 30)

  • +8 more secondary outcomes

Study Arms (2)

rTMS treatment group

EXPERIMENTAL

treated with real rTMS 1800 pulses / day,for 10 days

Device: real rTMS

Sham rTMS treatment group

SHAM COMPARATOR

treated with sham rTMS 1800 pulses / day,for 10 days

Device: sham rTMS

Interventions

real rTMSDEVICE

treated with 1HZ rTMS 1800 pulses / day,for 10 days

rTMS treatment group
sham rTMSDEVICE

treated with sham rTMS 1800 pulses / day,for 10 days

Sham rTMS treatment group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed as essential tremor conforming to the diagnostic criteria for essential tremor in the tremor group of the International Parkinson's and Movement Disorders Society (IPMDS).
  • Signed informed consent form.

You may not qualify if:

  • Complicated with brain organic diseases, epilepsy, other mental diseases, family history of dementia, metal devices implanted in the body and any contraindications to TMS;
  • History of craniocerebral surgery;
  • TMS cannot cooperate;
  • TMS-EEG examination artifacts are obvious, or cannot be analyzed due to other technical reasons.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Affiliated Hospital of Soochow University

Suzhou, China

RECRUITING

Related Publications (10)

  • Gironell A, Kulisevsky J, Lorenzo J, Barbanoj M, Pascual-Sedano B, Otermin P. Transcranial magnetic stimulation of the cerebellum in essential tremor: a controlled study. Arch Neurol. 2002 Mar;59(3):413-7. doi: 10.1001/archneur.59.3.413.

    PMID: 11890845BACKGROUND

  • Lv Y, Wang M, Yang J, Shi J, Xuan T, Zhang J, Du D, Cheng J, Li H. Cerebellar repetitive transcranial magnetic stimulation versus propranolol for essential tremor. Brain Behav. 2023 Mar;13(3):e2926. doi: 10.1002/brb3.2926. Epub 2023 Feb 17.

    PMID: 36806734BACKGROUND

  • Louis ED, Ferreira JJ. How common is the most common adult movement disorder? Update on the worldwide prevalence of essential tremor. Mov Disord. 2010 Apr 15;25(5):534-41. doi: 10.1002/mds.22838.

    PMID: 20175185BACKGROUND

  • Louis ED. The Roles of Age and Aging in Essential Tremor: An Epidemiological Perspective. Neuroepidemiology. 2019;52(1-2):111-118. doi: 10.1159/000492831. Epub 2019 Jan 9.

    PMID: 30625472BACKGROUND

  • Bal N, Sengul Y, Behmen MB, Powell A, Louis ED. Vestibular reflexes in essential tremor: abnormalities of ocular and cervical vestibular-evoked myogenic potentials are associated with the cerebellum and brainstem involvement. J Neural Transm (Vienna). 2023 Dec;130(12):1553-1559. doi: 10.1007/s00702-023-02652-3. Epub 2023 May 18.

    PMID: 37199795BACKGROUND

  • Berkiten G, Tutar B, Atar S, Kumral TL, Salturk Z, Akan O, Sari H, Onaran O, Biltekin Tuna O, Uyar Y. Assessment of the Clinical Use of Vestibular Evoked Myogenic Potentials and the Video Head Impulse Test in the Diagnosis of Early-Stage Parkinson's Disease. Ann Otol Rhinol Laryngol. 2023 Jan;132(1):41-49. doi: 10.1177/00034894211067838. Epub 2022 Feb 3.

    PMID: 35114808BACKGROUND

  • Bayramoglu B, Emre U, Erdal Y, Demirhan H, Yasak I, Yalin OO. Cervical vestibular-evoked myogenic potentials in patients with essential tremor. J Clin Neurosci. 2021 Sep;91:365-368. doi: 10.1016/j.jocn.2021.07.015. Epub 2021 Jul 30.

    PMID: 34373053BACKGROUND

  • Jimenez-Jimenez FJ, Alonso-Navarro H, Garcia-Martin E, Agundez JAG. Sleep disorders in essential tremor: systematic review and meta-analysis. Sleep. 2020 Sep 14;43(9):zsaa039. doi: 10.1093/sleep/zsaa039.

    PMID: 32163585BACKGROUND

  • Bugalho P, Salavisa M, Borbinha C, Fernandes M, Meira B, Barbosa R, Mendonca M. REM sleep behaviour disorder in essential tremor: A polysomnographic study. J Sleep Res. 2021 Apr;30(2):e13050. doi: 10.1111/jsr.13050. Epub 2020 Apr 23.

    PMID: 32323893BACKGROUND

  • Rekik A, Nasri A, Mrabet S, Gharbi A, Souissi A, Gargouri A, Kacem I, Gouider R. Non-motor features of essential tremor with midline distribution. Neurol Sci. 2022 Oct;43(10):5917-5925. doi: 10.1007/s10072-022-06262-x. Epub 2022 Jul 18.

    PMID: 35849198BACKGROUND

MeSH Terms

Conditions

Essential Tremor

Condition Hierarchy (Ancestors)

Movement DisordersCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Chun-Feng Liu

    Second Affiliated Hospital of Soochow University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chun-Feng Liu, MD

CONTACT

+8613606210609liuchunfeng@suda.edu.cn

Xiao-Yu Cheng, MD

CONTACT

+8651267783307chengxiaoyu2007@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 12, 2023

First Posted

November 24, 2023

Study Start

November 7, 2023

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

November 24, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)