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The Study of Rest Tremor Suppression by Using Electrical Muscle Stimulation

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ClinicalTrials.gov Identifier: NCT02370108
Recruitment Status : Unknown
Verified February 2015 by Chulalongkorn University.
Recruitment status was:  Not yet recruiting
First Posted : February 24, 2015
Last Update Posted : February 24, 2015
Sponsor:
Information provided by (Responsible Party):
Chulalongkorn University

Brief Summary:
This study is aimed to study the safety and feasibility of electrical muscle stimulation (EMS) in suppression of tremor from various causes especially for rest tremor in Parkinson's disease.

Condition or disease Intervention/treatment Phase
Rest Tremor Parkinson's Disease Device: electrical muscle stimulation Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Study of Rest Tremor Suppression by Using Electrical Muscle Stimulation
Study Start Date : February 2015
Estimated Primary Completion Date : January 2016
Estimated Study Completion Date : May 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PD patient
Parkinson's disease patients will get the electrical muscle stimulation at the most tremulous hand at 50 Hz frequency, maximal tolerate pulse amplitude (not over 20 mA), duration of stimulation for 10 second.
Device: electrical muscle stimulation
electrical muscle stimulation at hand muscle for reduction tremor

Experimental: OT patients
others tremor patients will get the electrical muscle stimulation at the most tremulous hand at 50 Hz frequency, maximal tolerate pulse amplitude (not over 20 mA), duration of stimulation for 10 second.
Device: electrical muscle stimulation
electrical muscle stimulation at hand muscle for reduction tremor




Primary Outcome Measures :
  1. Number of participant who had tremor suppression determine by reduction of tremor rating scale during electrical muscle stimulation [ Time Frame: up to 1 month follow up ]
    To determine the number of participant with tremor suppression during electrical muscle stimulation


Secondary Outcome Measures :
  1. Number of participant who report pain or any adverse events from electrical muscle stimulation [ Time Frame: up to 1 month follow up ]
    To determine number of participant who report pain or adverse events from electrical muscle stimulation

  2. The severity of pain related from electrical muscle stimulation by visual analog scale [ Time Frame: intraoperative ]
    To determine the severity of pain related from electrical muscle stimulation by visual analog scale



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • For PD patients

    • Adults ≥ 18 years old.
    • Patients with Parkinson's disease diagnosed according to the UKPDSBB criteria with predominantly feature of rest tremor that intractable to medically treatment.
    • Informed consent For other tremor patients
    • Adults ≥ 18 years old.
    • Patients with essential tremor diagnosed according to the TRIG criteria for essential tremor or patients with dystonic tremor diagnosed according to the proposed definition in which their symptoms shared similar trait of medically intractable tremor.
    • Informed consent

Exclusion Criteria:

  • For PD patients

    • Patients with a history of cardiac arrhythmia, renal failure, hepatic failure, and pregnancy as well as those who had history of seizure or had the risk for tended to become seizure such as those who had focal brain lesions, encephalitis, and stroke patients.
    • Patients with a history of hand surgery and implanted screws or wires in hand area that supposed to place a surface EMG or EMS, as well as those patients who were implanted for electrical devices such as cardiac pacemaker, pulse generator of deep brain stimulation,and intrathecal baclofen pump.
    • Patients who cannot avoid the medication that may potentiate or attenuate tremor such as antihistamines, benzodiazepine, illicit drugs, and thyroid hormone supplement.

For other tremor patients

  • Patients with a history of cardiac arrhythmia, renal failure, hepatic failure, and pregnancy as well as those who had history of seizure or had the risk for tended to become seizure such as those who had focal brain lesions, encephalitis, and stroke patients.
  • Patients with a history of hand surgery and implanted screws or wires in hand area that supposed to place a surface EMG or EMS, as well as those patients who were implanted for electrical devices such as cardiac pacemaker, pulse generator of deep brain stimulation, and intrathecal baclofen pump.
  • Patients who cannot avoid the medication that may potentiate or attenuate tremor such as antihistamines, benzodiazepine, illicit drugs, and thyroid hormone supplement.

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): NCT02370108


Contacts
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Contact: Onanong Jitkritsadakul, MD, MSc 0863570212 onanong.jit@gmail.com
Contact: Roongroj Bhidayasiri, MD, FRCP 022564630 rbh1@ucla.com

Sponsors and Collaborators
Chulalongkorn University
Investigators
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Study Director: Roongroj Bhidayasiri, MD, FRCP Chulalongkorn University
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Responsible Party: Chulalongkorn University
ClinicalTrials.gov Identifier: NCT02370108    
Other Study ID Numbers: 483/57
First Posted: February 24, 2015    Key Record Dates
Last Update Posted: February 24, 2015
Last Verified: February 2015
Keywords provided by Chulalongkorn University:
electrical muscle stimulation
parkinson's disease
rest tremor
tremor reduction
Additional relevant MeSH terms:
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Parkinson Disease
Tremor
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Dyskinesias
Neurologic Manifestations