Repetitive Transcranial Magnetic Stimulation Therapy in Essential Tremor

Essential Tremor Clinical Trial

— rTMS  

Official title:

the Effects of Repetitive Transcranial Magnetic Stimulation and Mechanisms in Clinical Function of Essential Tremor

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06145932
• Other study ID #: JD-LK2023096-IR01
• Status: Recruiting
• Phase: N/A
• Start date: November 7, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: November 2023
• Source: Second Affiliated Hospital of Soochow University
• Contact: Chun-Feng Liu, MD
• Phone: +8613606210609
• Email: liuchunfeng[@]suda.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2026
• Est. primary completion date: October 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Essential Tremor
• Tremor

Intervention

Device:
• real rTMS
treated with 1HZ rTMS 1800 pulses / day,for 10 days
• sham rTMS
treated with sham rTMS 1800 pulses / day,for 10 days

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Soochow University	Suzhou

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Soochow University

Country where clinical trial is conducted

China, 

References & Publications (10)

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 May 18. doi: 10.1007/s00702-023-02652-3. Online ahead of print. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Changes from baseline in TMS-EEG	Amplitudes of various frequency bands in each cortical region of TMS-EEG reflects change in the patient's brain network.	visit 1(baseline), visit 2(Day 10), visit 3(Day 30)
Secondary	Change in Non-Motor Symptoms Rating Scale (NMSS) score from baseline	This outcome reflects the efficacy of non-motor symptoms. NMSS is a widely used non-motor symptom rating scale that includes 9 domains, The NMSS score ranges from 0 to 360,with higher scores associated with more severe symptoms.	visit 1(baseline), visit 2(Day 10), visit 3(Day 30)
Secondary	Change in Mini-Mental State Examination (MMSE) score from baseline	The MMSE is widely used to assess cognition. The MMSE score ranges from 0 to 30. The higher the MMSE score is, the better the cognitive function is.	visit 1(baseline), visit 2(Day 10), visit 3(Day 30)
Secondary	Change in Montreal Cognitive Assessment (MOCA) score from baseline	MoCA is widely used to assess cognitive abilities. MOCA scores range from 0 to 30. The higher the MOCA score, the better the cognitive function.	visit 1(baseline), visit 2(Day 10), visit 3(Day 30)
Secondary	Changes from baseline in Hamilton Anxiety Scale(HAMA) score	The Hamilton Anxiety Scale(HAMA) is a widely used interview scale to measure the severity of a patient's anxiety.The HAMA score can range from 0 to 56. The higher the HAMA score is, the worse the symptoms are.	visit 1(baseline), visit 2(Day 10), visit 3(Day 30)
Secondary	Changes from baseline in Hamilton Depression Scale-24(HAMD-24) score	The Hamilton Depression Scale-24(HAMD-24) is a test measuring the severity of depressive symptoms in individuals. The HAMA score can range from 0 to 56. The higher the HAMA score is, the worse the symptoms are.	visit 1(baseline), visit 2(Day 10), visit 3(Day 30)
Secondary	Quality of Life Questionnaire (QUEST) score change from baseline	This outcome reflects the patient's quality of life. QUEST scores range from 0 to 120.; The higher the QUEST score, the more severe the symptoms.	visit 1(baseline), visit 2(Day 10), visit 3(Day 30)
Secondary	Change in Pittsburgh Sleep Quality Index (PSQI) score from baseline	PSQI is widely used to measure sleep quality. PSQI scores range from 0 to 21. The higher the PSQI score, The worse the quality of sleep.	visit 1(baseline), visit 2(Day 10), visit 3(Day 30)
Secondary	Change in Fatigue Severity Scale (FSS) score from baseline	FSS is widely used in the assessment of fatigue. Indicates a health problem associated with fatigue. The higher the score, the worse the fatigue	visit 1(baseline), visit 2(Day 10), visit 3(Day 30)
Secondary	RBD Screening Questionnaire (RBDSQ) score	There are 10 questions in total, including the content of dreams, the relationship between dreams and behavior, injuries and neurological diseases, etc. The total score is 0-13 points, and a score of 5 or above is considered abnormal.	visit 1(baseline)
Secondary	Test the sleep characteristics by polysomnography (PSG)	This outcome reflects the patient's sleep characteristics and to analyze specific events.	visit 1(baseline)
Secondary	test the characteristics of vestibular evoked myogenic potential (VEMP)	This is a commonly used clinical test that includes cervical vestibular evoked myogenic potential (cvemp) and ocular vestibular evoked myogenic potential (oVEPM) to assess a patient's brainstem pathways.	visit 1(baseline)
Secondary	test the gene's type of the notch2nlc	This outcome reflects the genetic diagnosis characteristics of the patient and is helpful for accurate clinical diagnosis and classification	visit 1(baseline)