Repetitive Transcranial Magnetic Stimulation Therapy in Essential Tremor

NCT ID: NCT06145932

Last Updated: 2023-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-07

Study Completion Date

2026-12-31

Brief Summary

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

Detailed Description

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This is a randomized controlled study.The purpose is to evaluate the efficacy of repetitive transcranial magnetic stimulation(rTMS) in the treatment of essential tremor,and explore the possible mechanism by detecting the changes of clinical scale and TMS-electroencephalogram(TMS-EEG), so as to seek an effective therapy for essential tremor.

Conditions

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Essential Tremor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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rTMS treatment group

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

Group Type EXPERIMENTAL

real rTMS

Intervention Type DEVICE

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

Sham rTMS treatment group

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

Group Type SHAM_COMPARATOR

sham rTMS

Intervention Type DEVICE

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

Interventions

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real rTMS

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

Intervention Type DEVICE

sham rTMS

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. 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).
2. Signed informed consent form.

Exclusion Criteria

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

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital of Soochow University

OTHER

Sponsor Role lead

Responsible Party

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Chun-Feng Liu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chun-Feng Liu

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital of Soochow University

Locations

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The Second Affiliated Hospital of Soochow University

Suzhou, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Chun-Feng Liu, MD

Role: CONTACT

+8613606210609

Xiao-Yu Cheng, MD

Role: CONTACT

+8651267783307

Facility Contacts

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yu xiao chen, PHD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 11890845 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36806734 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20175185 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30625472 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37199795 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35114808 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34373053 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32163585 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32323893 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35849198 (View on PubMed)

Other Identifiers

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JD-LK2023096-IR01

Identifier Type: -

Identifier Source: org_study_id