Transcranial Direct Current Stimulation of the Motor Cortex in Essential Tremor

NCT03952117 | Unknown DMC FDA Device

• 1 other identifier: LAUMCRH.RA3.11/Apr/2019
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Essential Tremor; Transcranial Direct Current Stimulation

Keywords

primary motor cortex

Outcome Measures

Primary Outcomes (1)

• Tremor amplitude

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

  5 days

Secondary Outcomes (1)

• Functional impact of tremor

  19 days

Study Arms (2)

Active tDCs

ACTIVE COMPARATOR

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

Sham tDCS

SHAM COMPARATOR

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

Interventions

transcranial direct current stimulation DEVICE

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).

Active tDCs; Sham tDCS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lebanese American University: lead

Study Sites (1)

LAUMCRH

Beirut, Lebanon

RECRUITING

MeSH Terms

Conditions

Essential Tremor

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Rechdi Ahdab

  Lebanese American University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Naji Riachi, MD

CONTACT

009611200800; Naji.riachi@lau.edu.lb

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D , PhD

Study Record Dates

• First Submitted: May 14, 2019
• First Posted: May 16, 2019
• Study Start: July 19, 2019
• Primary Completion: June 1, 2021
• Study Completion: October 1, 2021
• Last Updated: August 13, 2019

Record last verified: 2019-08

Locations

LE (1)