Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Transcranial Direct Current Stimulation of the Motor Cortex in Essential Tremor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03952117
Recruitment Status : Unknown
Verified August 2019 by Rechdi Ahdab, Lebanese American University.
Recruitment status was:  Recruiting
First Posted : May 16, 2019
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Rechdi Ahdab, Lebanese American University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

The current research is aimed at using Transcranial Direct Current Stimulation (tDCS) as complementary therapeutic tool in the treatment of essential tremor. Patients will be randomized into two groups (tDCS-cathode vs. tDCS-sham) according to detailed protocol. Main outcome will be measured by the change in tremor amplitude using an accelerometer pre and post cathodal tDCS of the motor cortex.

A total of 40 patients ought to be enrolled as specified in methodology. Secondary outcomes will assess TRG essential tremor rating assessment scale (TETRAS) as well as clinical monitoring.


Condition or disease Intervention/treatment Phase
Essential Tremor Transcranial Direct Current Stimulation Device: transcranial direct current stimulation Not Applicable

Detailed Description:

Essential tremor (ET) is a common progressive neurological disorder and is the most common movement disorder. Worldwide , up to 5% of the population suffer from this disorder with an increased incidence with advanced age.

The proposed mechanism that underlies ET, the central oscillating network, is mainly composed of the olivocerebellar system, thalamus and motor cortex. An interruption in this circuit limits the ability of the cortex to reorganize and restore ET. a case of 76 year old female with essential tremor that disappeared following a cortico-subcortical prerolandic stroke despite complete motor recovery highlights the role of the motor cortex in the production and possible therapeutic role of the transcranial direct current stimulation.

Study design A randomized, sham-controlled, double blind and crossover study.

Study procedure:

The first visit is an inclusion visit Prior to starting the first tDCS session, the patient will be asked to fill his/her first TRG essential tremor assessment (TETRAS) scale. The physician will then quantitatively analyze the tremor on the most affected side using an accelerometer. Cathodal tDCS will be administered on the area representing the primary motor cortex and the anode over the contralateral supraorbital area. tDCS stimulation (cathodal and sham) will be done daily for 5 consecutive days during weeks 1 and 5. Each stimulation session will last 30 minutes. tDCS will be performed while the patient is at rest, without any concurrent cognitive or motor task.The two tDCS sessions will be separated by a 23 day washout period.

Patient will be asked to fill out their TETRAS at days 1 and 5 of each tDCS session (cathodal and sham), and days 12 and 19 after each tDCS session (cathodal and sham).

Accelerometer assessment of the tremor will be performed at days 1 and 5 of each tDCS stimulation session (cathodal and sham).

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transcranial Direct Current Stimulation of the Motor Cortex in Essential Tremor : A Randomized Controlled Pilot Study
Actual Study Start Date : July 19, 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: Active tDCs
Active tDCS will be administered through a pair of conductive rubber electrodes covered by saline soaked sponges (35 cm2). The current will be delivered continuously at 2 mA for 30 min through a battery-driven constant-current stimulator. The cathode will be positioned facing the primary motor cortex area and the anode over the contralateral supraorbital area.
 Device: transcranial direct current stimulation
tDCS will be administered through a pair of conductive rubber electrodes covered by saline soaked sponges (35 cm2). The current will be delivered continuously at 2 mA for 30 min through a battery-driven constant-current stimulator (Sooma Oy, Helsinki, Finland).
Sham Comparator: Sham tDCS
Sham stimulation will be delivered to the motor cortex using a sham tDCS device that delivers a direct current for 10 seconds at the beginning and end of tDCS to provide sensory experiences similar to active stimulation.
 Device: transcranial direct current stimulation
tDCS will be administered through a pair of conductive rubber electrodes covered by saline soaked sponges (35 cm2). The current will be delivered continuously at 2 mA for 30 min through a battery-driven constant-current stimulator (Sooma Oy, Helsinki, Finland).


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Tremor amplitude [ Time Frame: 5 days ]
    Change in tremor amplitude using an accelerometer pre and post cathodal tDCS of the motor cortex.


Secondary Outcome Measures :
  1. Functional impact of tremor [ Time Frame: 19 days ]
    Assess change from baseline of the functional impact of tremor using the TETRAS scale


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Patients who fulfil the 2017 Movement society concusses statement criteria for essential tremor

Exclusion Criteria:

  • Isolated focal tremor (voice, head)
  • Orthostatic tremor with a frequency of more than 12 Hz
  • Task and position specific tremor
  • Sudden onset and stepwise deterioration of tremor
  • History of substance abuse or dependence in the past
  • Co-morbid medical conditions capable of producing or enhancing tremors
  • Use of a medication with potential effect on tremor
  • History of neurological disorders, brain tumors, brain surgery or abnormal neurological examination
  • Epileptic disorders
  • Cardiac pacemakers
  • Metallic hardware in the head or scalp (surgical clips)
  • Eczema or skin abrasion at the intended site of stimulation
  • Currently pregnant or plan for pregnancy in the next 6 months
  • Patients with prior experience with tDCS
  • Major psychosocial problems or medical problems rendering informed consent impossible
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03952117


Contacts
Layout table for location contacts
Contact: Naji Riachi, MD 009611200800 ext 6312 Naji.riachi@lau.edu.lb

Locations
Layout table for location information
Lebanon
LAUMCRH Recruiting
Beirut, Lebanon
Contact: Naji Riachi, MD    009611200800 ext 6312    Naji.riachi@lau.edu   
Sponsors and Collaborators
Lebanese American University
Investigators
Layout table for investigator information
Principal Investigator: Rechdi Ahdab Lebanese American University Medical Center
  Study Documents (Full-Text)

Documents provided by Rechdi Ahdab, Lebanese American University:
Study Protocol  [PDF] April 11, 2019

More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Rechdi Ahdab, M.D , PhD, Lebanese American University
ClinicalTrials.gov Identifier: NCT03952117    
Other Study ID Numbers: LAUMCRH.RA3.11/Apr/2019
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Rechdi Ahdab, Lebanese American University:
primary motor cortex
Additional relevant MeSH terms:
Layout table for MeSH terms
Tremor
Essential Tremor
Dyskinesias
Neurologic Manifestations
 Nervous System Diseases
Movement Disorders
Central Nervous System Diseases