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NCT Number: NCT06145932

Repetitive Transcranial Magnetic Stimulation Therapy in Essential Tremor

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

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Key information

Conditions

Essential Tremor Central Nervous System Diseases Movement Disorders Nervous System Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Second Affiliated Hospital of Soochow University

Suzhou, China

Location status: Recruiting

Location contact

yu xiao chen, PHD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Real rTMS

Device

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

sham rTMS

Device

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

Primary outcomes

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

    Time frame: visit 1(baseline), visit 2(Day 10), visit 3(Day 30)

    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.

  2. Changes from baseline in tremor analysis

    Time frame: visit 1(baseline), visit 2(Day 10), visit 3(Day 30)

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

Secondary outcomes

  1. Changes from baseline in TMS-EEG

    Time frame: visit 1(baseline), visit 2(Day 10), visit 3(Day 30)

    Amplitudes of various frequency bands in each cortical region of TMS-EEG reflects change in the patient's brain network.

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

    Time frame: visit 1(baseline), visit 2(Day 10), visit 3(Day 30)

    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.

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

    Time frame: visit 1(baseline), visit 2(Day 10), visit 3(Day 30)

    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.

  4. Change in Montreal Cognitive Assessment (MOCA) score from baseline

    Time frame: visit 1(baseline), visit 2(Day 10), visit 3(Day 30)

    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.

  5. Changes from baseline in Hamilton Anxiety Scale(HAMA) score

    Time frame: visit 1(baseline), visit 2(Day 10), visit 3(Day 30)

    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.

  6. Changes from baseline in Hamilton Depression Scale-24(HAMD-24) score

    Time frame: visit 1(baseline), visit 2(Day 10), visit 3(Day 30)

    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.

  7. Quality of Life Questionnaire (QUEST) score change from baseline

    Time frame: visit 1(baseline), visit 2(Day 10), visit 3(Day 30)

    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.

  8. Change in Pittsburgh Sleep Quality Index (PSQI) score from baseline

    Time frame: visit 1(baseline), visit 2(Day 10), visit 3(Day 30)

    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.

  9. Change in Fatigue Severity Scale (FSS) score from baseline

    Time frame: visit 1(baseline), visit 2(Day 10), visit 3(Day 30)

    FSS is widely used in the assessment of fatigue. Indicates a health problem associated with fatigue. The higher the score, the worse the fatigue

  10. RBD Screening Questionnaire (RBDSQ) score

    Time frame: visit 1(baseline)

    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.

  11. Test the sleep characteristics by polysomnography (PSG)

    Time frame: visit 1(baseline)

    This outcome reflects the patient's sleep characteristics and to analyze specific events.

  12. test the characteristics of vestibular evoked myogenic potential (VEMP)

    Time frame: visit 1(baseline)

    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.

  13. test the gene's type of the notch2nlc

    Time frame: visit 1(baseline)

    This outcome reflects the genetic diagnosis characteristics of the patient and is helpful for accurate clinical diagnosis and classification

Study contacts

Contact information is provided by the study sponsor or research team.

Chun-Feng Liu, MD

CONTACT

[email protected]

+8613606210609

Xiao-Yu Cheng, MD

CONTACT

[email protected]

+8651267783307

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Soochow University

Other

Registry information

Official study title

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

Acronym: rTMS

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Nov 24, 2023
Registry last updated
Nov 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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