In this study we aim to evaluate the effectiveness of repetitive transcranial magnetic stimulation (rTMS) of the cerebellum on motor symptoms of patients with essential tremor. We will recruit at least 30 subjects who have diagnosed as essential tremor based on the Movement Disorder Society criteria with involvement of at least one hand among patients visiting at the Specialty Clinic of Mashhad Medical University 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.
General information
Acronym
Cerebellar rTMS for essential tremor
IRCT registration information
IRCT registration number:IRCT2015100824428N1
Registration date:2016-04-01, 1395/01/13
Registration timing:prospective
Last update:
Update count:1
Registration date
2016-04-01, 1395/01/13
Registrant information
Name
Nahid Olfati
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3842 9828
Email address
olfatin921@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Vice Chancellor, Mashhad University of Medical Sciences
Expected recruitment start date
2016-04-10, 1395/01/22
Expected recruitment end date
2017-05-31, 1396/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing clinical effectiveness of cerebellar repetitive transcranial magnetic stimulation (rTMS) on severity of motor signs of essential tremor.
Public title
Assessing the effectiveness of repetitive Transcranial Magnetic Stimulation (rTMS) of the cerebellum in treatment of essential tremor.
Purpose
Treatment
Inclusion/Exclusion 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
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
1
Registry name
ClinicalTrials.gov
Secondary trial Id
NCT02704793
Registration date
2016-03-09, 1394/12/19
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Mashhad University of Medical Sciences
Street address
Sakhteman-e-Ghoreishi, Daneshgah St., Research Ethics Committee
City
Mashhad
Postal code
91375-345
Approval date
2015-09-23, 1394/07/01
Ethics committee reference number
ir.mums.sm.rec.1394.353
Health conditions studied
1
Description of health condition studied
Essential Tremor
ICD-10 code
G25.0
ICD-10 code description
Essential Tremor
Primary outcomes
1
Description
Tremor severity
Timepoint
At the baseline and on days 5, 12, 30 after each real or sham treatment session
Method of measurement
Fahn-Tolosa-Marin scale
Secondary outcomes
empty
Intervention groups
1
Description
Sham treatment (electrical stimulation of less than 3 mili amperes) using a small device located on the coil, invisible to the patient, providing 900 pulses on each cerebellar hemisphere daily for 5 days.
Category
Placebo
2
Description
Bilateral Cerebellar rTMS using the butterfly coil providing 900 pulses on each cerebellar hemispheres daily for 5 days.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Neurology, Ghaem Hospital
Full name of responsible person
Nahid Olfati
Street address
Department of Neurology, Ghaem hospital, Ahmad-abad st.
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Vice Chancellor of Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Research Vice Chancellor of Mashhad University of Medical Sciences, Sakhtemean -e- Ghoreishi, Daneshgah st.
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Vice Chancellor of Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Department of Neurology, Mashhad University of Medical Sciences
Full name of responsible person
Nahid Olfati
Position
Resident of Neurology
Other areas of specialty/work
Street address
Department of Neurology, Ghaem Hospital, Ahmad-abad st.
City
Mashhad
Postal code
91766-99199
Phone
+98 51 3842 9828
Fax
+98 51 3842 9828
Email
olfatin921@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Neurology, Mashhad University of Medical Sciences
Full name of responsible person
Ali Shoeibi
Position
Associate Professor of Neurology
Other areas of specialty/work
Street address
Department of Neurology, Ghaem Hospital, Ahmad-abad st.
City
Mashhad
Postal code
91766-99199
Phone
+98 51 3842 9828
Fax
Email
shoeibia@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Neurology, Mashhad University of Medical Sciences
Full name of responsible person
Nahid Olfati
Position
Resident of Neurology
Other areas of specialty/work
Street address
Department of Neurology, Ghaem Hospital, Ahmad-abad st.
City
Mashhad
Postal code
91766-99199
Phone
+98 51 3842 9828
Fax
+98 51 3842 9828
Email
olfatin921@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)