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Transcranial Direct Current Stimulation of the Motor Cortex in Essential Tremor

Primary Purpose

Essential Tremor, Transcranial Direct Current Stimulation

Status
Unknown status
Phase
Not Applicable
Locations
Lebanon
Study Type
Interventional
Intervention
transcranial direct current stimulation
Sponsored by
Lebanese American University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Essential Tremor focused on measuring primary motor cortex

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • LAUMCRHRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Active tDCs

Sham tDCS

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Tremor amplitude
Change in tremor amplitude using an accelerometer pre and post cathodal tDCS of the motor cortex.

Secondary Outcome Measures

Functional impact of tremor
Assess change from baseline of the functional impact of tremor using the TETRAS scale

Full Information

First Posted
May 14, 2019
Last Updated
August 12, 2019
Sponsor
Lebanese American University
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1. Study Identification

Unique Protocol Identification Number
NCT03952117
Brief Title
Transcranial Direct Current Stimulation of the Motor Cortex in Essential Tremor
Official Title
Transcranial Direct Current Stimulation of the Motor Cortex in Essential Tremor : A Randomized Controlled Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 19, 2019 (Actual)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
October 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lebanese American University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Tremor, Transcranial Direct Current Stimulation
Keywords
primary motor cortex

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active tDCs
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Sham tDCS
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
transcranial direct current stimulation
Intervention Description
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).
Primary Outcome Measure Information:
Title
Tremor amplitude
Description
Change in tremor amplitude using an accelerometer pre and post cathodal tDCS of the motor cortex.
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Functional impact of tremor
Description
Assess change from baseline of the functional impact of tremor using the TETRAS scale
Time Frame
19 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Naji Riachi, MD
Phone
009611200800
Ext
6312
Email
Naji.riachi@lau.edu.lb
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rechdi Ahdab
Organizational Affiliation
Lebanese American University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
LAUMCRH
City
Beirut
Country
Lebanon
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naji Riachi, MD
Phone
009611200800
Ext
6312
Email
Naji.riachi@lau.edu

12. IPD Sharing Statement

Learn more about this trial

Transcranial Direct Current Stimulation of the Motor Cortex in Essential Tremor

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