Cerebellar rTMS for Essential Tremor

NCT02704793 | Completed

• 1 other identifier: 940597
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• change in score of Fahn-Tolosa-Marin scale

  at the baseline and on days 5, 12, and 30 after each real or sham treatment session.

Study Arms (2)

Bilateral 1 Hz Cerebellar rTMS

EXPERIMENTAL

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

Sham (electrical stimulation)

SHAM COMPARATOR

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)

Interventions

Bilateral 1 Hz Cerebellar rTMS 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.

Bilateral 1 Hz Cerebellar rTMS

Sham (electrical stimulation) OTHER

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

Sham (electrical stimulation)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mashhad University of Medical Sciences: lead

Study Sites (1)

Department of Neurology, Ghaem Hospital

Mashhad, Razavi Khorasan Province, 91766-99199, Iran

Location

MeSH Terms

Conditions

Essential Tremor

Interventions

salicylhydroxamic acid; Electric Stimulation

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Physical Stimulation; Investigative Techniques

Study Officials

• Ali Shoeibi, MD

  Mashhad University of Medical Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: March 5, 2016
• First Posted: March 10, 2016
• Study Start: April 1, 2016
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: May 22, 2018

Record last verified: 2018-05

Locations

IR (1)