Investigating the effect of cerebellar transcranial electric stimulation on the hand tremor in Parkinson's patients in two groups of intervention and sham.
Design
Clinical trials with intervention and sham group with single group, one blind, randomized clinical trial.
Settings and conduct
The study place is Firoozgar Hospital in Tehran. In the field of rehabilitation and improvement of Parkinson's patients. In an electrical stimulation session, a current of 2 mA was applied to the cerebellum for 15 minutes. The participant is blinded by which group (sham, intervention) participates.
Participants/Inclusion and exclusion criteria
Parkinson’s patients should be a predominant tremor.
Could not be withdrawn from antiparkinsonian drugs for 8 hours.
There is no implant, rubbing or any metal object in the patient's body. No History of seizure and epilepsy. They don't have other neuropsychiatric diseases. They weren't being treated with deep brain stimulation.
Intervention groups
In the intervention group, the 2 mA electric current is applied to the cerebellum by an active electrode for 15 minutes, and in the sham group, the electric current of 2 mA in 30 seconds is applied and then stopped.
Main outcome variables
The amplitude of acceleration; Frequency of acceleration
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190306042945N2
Registration date:2019-04-24, 1398/02/04
Registration timing:registered_while_recruiting
Last update:2019-04-24, 1398/02/04
Update count:0
Registration date
2019-04-24, 1398/02/04
Registrant information
Name
Bijan Forogh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8214 1612
Email address
forogh.b@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2019-09-23, 1398/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Effect of Transcranial Electric Stimulation on Hand Tremor in Parkinson's Patients
Public title
Effect of Non-invasive Electric Stimulation on Hand Tremor in Parkinson's Patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Parkinson’s patients should be a predominant tremor.
Could not be withdrawn from antiparkinsonian drugs for 8 hours.
Exclusion criteria:
There is implant, rubbing or any metal object in the patient's body.
History of seizure and epilepsy.
They have other neuropsychiatric diseases.
They were being treated with deep brain stimulation
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
38
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization has been used.
Blinding (investigator's opinion)
Single blinded
Blinding description
The participant is blinded by which group (sham, intervention) participates. In sham, only the first 30 seconds the electric current is applied to give emotions and signs of current, and after 30 seconds the current flow stops.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University of Medical Sciences
Street address
Next to the Milad tower, Hemmat highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2019-02-24, 1397/12/05
Ethics committee reference number
IR.IUMS.REC.1397.1349
Health conditions studied
1
Description of health condition studied
Parkinson's disease
ICD-10 code
G20
ICD-10 code description
Parkinson's disease
Primary outcomes
1
Description
Amplitude of acceleration of the hand
Timepoint
Measure the acceleration of the hand before and after the intervention
Method of measurement
Accelerometer has LIS3DH sensor
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: To this group a cerebellum transcranial alternating electric stimulation with a current intensity of 2 mA and the peak frequency of each person in 15 minutes applied in a session.
Category
Rehabilitation
2
Description
Control group: For sham stimulation, sponge electrodes were applied in the same manner. The session times is 15 minutes, with only ramp running in about 30 seconds.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul Akram Hospital
Full name of responsible person
Soraya Rahimi
Street address
Maziar Mansouri Ave., Sattarkhan St.
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6651 5001
Email
research@iums.ac.ir
Web page address
http://hrmc.iums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyyed Kazam Malakouti
Street address
Tehran, Hemat Highway next to Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Email
research@iums.ac.ir
Web page address
http://vcr.iums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Information on the main outcome can be shared.
When the data will become available and for how long
The beginning of the access period is one year after the publication of the results in valid journals.
To whom data/document is available
Students
Under which criteria data/document could be used
To use data, the name of the data collector group should be mentioned in their study.
The purpose and application of the data are explained in their study.
From where data/document is obtainable
By sending an email to "forogh.b@iums.ac.ir"; "soraya.rahimi@aut.ac.ir"
What processes are involved for a request to access data/document