Repetitive Transcranial Magnetic Stimulation Therapy in Essential Tremor

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSecond Affiliated Hospital of Soochow University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: rTMS treatment groupExperimental treatment 1 intervention
Group B: Sham rTMS treatment groupSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

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

Changes from baseline in tremor analysis

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

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

Secondary outcomes

1

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.

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

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.

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

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.

Time frame
visit 1(baseline), visit 2(Day 10), visit 3(Day 30)
4

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.

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

Other outcomes

Sponsors and contacts

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