Cerebellar rTMS for Essential Tremor

NCT ID: NCT02704793

Last Updated: 2018-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2018-05-31

Brief Summary

Essential tremor (ET) is a low-mortality, though truly burdensome and debilitating condition which is known to be the second most common movement disorder of the adult population only after restless legs syndrome. The prevalence of the disorder in all age groups has been estimated to be 0.9%. Repetitive transcranial magnetic stimulation (rTMS) is an almost safe technique which has been used in diagnosis and treatment of many neurologic and psychiatric conditions. Recent studies have shown that cerebellum has a significant role in development of ET and that rTMS could exert therapeutic effects on its motor symptoms. In this study researchers will recruit at least 30 subjects among patients visiting at the Specialty Clinic of Mashhad Medical University according to researchers exclusion and inclusion criteria and after signing a written informed consent, will randomly be assigned to either real or sham rTMS. On the real rTMS arm, patients will be treated with 900 pulses of 1 Hz rTMS on 90% of resting motor threshold (RMT) delivered over each cerebellar hemisphere for 5 consecutive days and sham treatment will be performed with the same protocol using a small device placed on the TMS coil (not visible to the patients) producing electrical stimulation (less than 3 mili amperes), to simulate the sensation of real TMS. Subject's ear will be protected with earplugs during both real and sham stimulations. After 2 months of follow-up, patients will undergo crossover and receive the other treatment as described above. Patients would be assessed using Fahn-Tolosa-Marin scale at the baseline and again on days 5, 12, and 30 after each real or sham treatment session by a blinded researcher. Data will be analysed by another researcher who is also blind.

Conditions

Essential Tremor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Bilateral 1 Hz Cerebellar rTMS

Patients will be treated with 900 pulses of 1 Hz rTMS on 90% of resting motor threshold (RMT) delivered over each cerebellar hemisphere for 5 consecutive days.

Group Type: EXPERIMENTAL

Bilateral 1 Hz Cerebellar rTMS

Intervention Type: OTHER

900 pulses of 1 Hz rTMS on 90% of resting motor threshold (RMT) delivered over each cerebellar hemisphere every day for 5 consecutive days.

Sham (electrical stimulation)

Sham treatment will be performed with the same protocol using a small device placed on the TMS coil (not visible to the patients) producing electrical stimulation (less than 3 mili amperes), to simulate the sensation of real TMS.

Group Type: SHAM_COMPARATOR

Sham (electrical stimulation)

Intervention Type: OTHER

900 pulses of 1 Hz electrical stimulation (less than 3 mili amperes) delivered over each cerebellar hemisphere every day for 5 consecutive days.

Interventions

Bilateral 1 Hz Cerebellar rTMS

900 pulses of 1 Hz rTMS on 90% of resting motor threshold (RMT) delivered over each cerebellar hemisphere every day for 5 consecutive days.

Intervention Type: OTHER

Sham (electrical stimulation)

900 pulses of 1 Hz electrical stimulation (less than 3 mili amperes) delivered over each cerebellar hemisphere every day for 5 consecutive days.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• having a diagnosis of essential tremor (ET) based on Movement Disorder Society criteria, involving at least one hand.
• 18 years or above
• cognitively eligible to give informed consent of participation in the trial.

Exclusion Criteria

• Cardiac pace-maker or other implanted magnetic device or having other contraindications of performing a routine non-contrast MRI
• skin defect at the occipital area preventing placement of a coil
• Currently pregnant or plan for pregnancy in the next 6 months
• History of seizure
• Other comorbid medical conditions capable of producing or enhancing tremor
• advanced cardiac, renal, hepatic or other disabling conditions making patient physical unable to participate in examination and receiving the intervention
• Use of new drugs with potential effect on tremor

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mashhad University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Nahid Olfati

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ali Shoeibi, MD

Role: STUDY_DIRECTOR

Mashhad University of Medical Sciences

Locations

Department of Neurology, Ghaem Hospital

Mashhad, Razavi Khorasan Province, Iran

Countries

Iran

Other Identifiers

940597

Identifier Type: -

Identifier Source: org_study_id