Cerebellar rTMS for Essential Tremor

May 20, 2018 updated by: Nahid Olfati, Mashhad University of Medical Sciences

Assessing Clinical Effectiveness of Cerebellar Repetitive Transcranial Magnetic Stimulation (rTMS) on Severity of Motor Signs of Essential Tremor

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
    • Razavi Khorasan
      • Mashhad, Razavi Khorasan, Iran, Islamic Republic of, 91766-99199
        • Department of Neurology, Ghaem Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: 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.
Sham Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change in score of Fahn-Tolosa-Marin scale
Time Frame: at the baseline and on days 5, 12, and 30 after each real or sham treatment session.
at the baseline and on days 5, 12, and 30 after each real or sham treatment session.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mashhad University of Medical Sciences

Investigators

  • Study Director: Ali Shoeibi, MD, Mashhad University Of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2016

Primary Completion (Actual)

May 1, 2018

Study Completion (Actual)

May 1, 2018

Study Registration Dates

First Submitted

March 5, 2016

First Submitted That Met QC Criteria

March 9, 2016

First Posted (Estimate)

March 10, 2016

Study Record Updates

Last Update Posted (Actual)

May 22, 2018

Last Update Submitted That Met QC Criteria

May 20, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 940597

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Considering ethical issues the investigators keep patients' data protected, however these data could be provided for further analysis by other investigators upon acceptance of the Mashhad University of Medical Sciences, Research Ethics Board Committee's subject data protection regulations.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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