Protocol summary
-
Study aim
-
To evaluate the effectiveness of low frequency repetitive transcranial magnetic stimulation (rTMS) of the cerebellum on essential tremor
-
Design
-
Randomized double blind sham controlled crossover clinical trail
-
Settings and conduct
-
Patients visited at the Neurology Specialty Clinic of Mashhad Medical University. patients and outcome assessor were blinded.
-
Participants/Inclusion and 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
-
Intervention groups
-
900 pulses of 1 Hz rTMS on 90% of resting motor threshold (RMT) delivered over each cerebellar hemisphere for 5 consecutive days
-
Main outcome variables
-
Tremor severity based on Fahn-Tolosa-Marin scale
General information
-
Reason for update
-
To update the trial status
-
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:
2019-12-25, 1398/10/04
Update count:
1
-
Registration date
-
2016-04-01, 1395/01/13
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
Research Vice Chancellor, Mashhad University of Medical Sciences
-
Expected recruitment start date
-
2016-05-21, 1395/03/01
-
Expected recruitment end date
-
2017-05-22, 1396/03/01
-
Actual recruitment start date
-
2016-05-21, 1395/03/01
-
Actual recruitment end date
-
2017-11-22, 1396/09/01
-
Trial completion date
-
2018-03-22, 1397/01/02
-
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
Involvement of at least one hand
Cognitively eligible to give informed consent of participation in the trial
18 years or above
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 medications with potential effect on tremor
-
Age
-
From 18 years old
-
Gender
-
Both
-
Phase
-
N/A
-
Groups that have been masked
-
- Participant
- Outcome assessor
-
Sample size
-
Target sample size:
30
Actual sample size reached:
23
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
Block randomization using sealed envelops
-
Blinding (investigator's opinion)
-
Double blinded
-
Blinding description
-
Participants: by use of sham procedure
Outcome assessor: an investigator blinded to the type of intervention assessed outcome and another investigator performed data entry and analysis
-
Placebo
-
Used
-
Assignment
-
Crossover
-
Other design features
-
Secondary Ids
1
-
Registry name
-
ClinicalTrials.gov
-
Secondary trial Id
-
NCT02704793
-
Registration date
-
2016-03-10, 1394/12/20
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2015-10-07, 1394/07/15
-
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
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
1
-
Sponsor
-
-
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
-
Public
-
Domestic or foreign origin
-
Domestic
-
Category of foreign source of funding
-
empty
-
Country of origin
-
-
Type of organization providing the funding
-
Academic
Sharing plan
-
Deidentified Individual Participant Data Set (IPD)
-
Yes - There is a plan to make this available
-
Study Protocol
-
Yes - There is a plan to make this available
-
Statistical Analysis Plan
-
Yes - There is a plan to make this available
-
Informed Consent Form
-
Undecided - It is not yet known if there will be a plan to make this available
-
Clinical Study Report
-
Yes - There is a plan to make this available
-
Analytic Code
-
Not applicable
-
Data Dictionary
-
Not applicable
-
Title and more details about the data/document
-
Data file is available along with the submitted manuscript
-
When the data will become available and for how long
-
Anonymized data is available open access
-
To whom data/document is available
-
open access
-
Under which criteria data/document could be used
-
Academics might use data provided that funding sources are cited and contacted
-
From where data/document is obtainable
-
contact publisher of our final manuscript
-
What processes are involved for a request to access data/document
-
doi:10.1016/j.brs.2019.10.003
or contact corresponding author shoeibia@mums.ac.ir
-
Comments
-