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出境医 / 临床实验 / Transcranial Direct Current Stimulation of the Motor Cortex in Essential Tremor

Transcranial Direct Current Stimulation of the Motor Cortex in Essential Tremor

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.


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
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
Arms and Interventions
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
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
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

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
Tracking Information
First Submitted Date  ICMJE May 14, 2019
First Posted Date  ICMJE May 16, 2019
Last Update Posted Date August 13, 2019
Actual Study Start Date  ICMJE July 19, 2019
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2019) 		Tremor amplitude [ Time Frame: 5 days ]
Change in tremor amplitude using an accelerometer pre and post cathodal tDCS of the motor cortex.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2019) 		Functional impact of tremor [ Time Frame: 19 days ]
Assess change from baseline of the functional impact of tremor using the TETRAS scale
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Transcranial Direct Current Stimulation of the Motor Cortex in Essential Tremor
Official Title  ICMJE Transcranial Direct Current Stimulation of the Motor Cortex in Essential Tremor : A Randomized Controlled Pilot Study
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Essential Tremor
  • Transcranial Direct Current Stimulation
Intervention  ICMJE 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).
Study Arms  ICMJE
  • 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.
    Intervention: Device: transcranial direct current stimulation
  • 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.
    Intervention: Device: transcranial direct current stimulation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 14, 2019) 		40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Naji Riachi, MD 009611200800 ext 6312 Naji.riachi@lau.edu.lb
Listed Location Countries  ICMJE Lebanon
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03952117
Other Study ID Numbers  ICMJE LAUMCRH.RA3.11/Apr/2019
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rechdi Ahdab, Lebanese American University
Study Sponsor  ICMJE Lebanese American University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rechdi Ahdab Lebanese American University Medical Center
PRS Account Lebanese American University
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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