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The Study of Rest Tremor Suppression by Using Electrical Muscle Stimulation

Primary Purpose

Rest Tremor, Parkinson's Disease

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
electrical muscle stimulation
Sponsored by
Chulalongkorn University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rest Tremor focused on measuring electrical muscle stimulation, parkinson's disease, rest tremor, tremor reduction

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    PD patient

    OT patients

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Number of participant who had tremor suppression determine by reduction of tremor rating scale during electrical muscle stimulation
    To determine the number of participant with tremor suppression during electrical muscle stimulation

    Secondary Outcome Measures

    Number of participant who report pain or any adverse events from electrical muscle stimulation
    To determine number of participant who report pain or adverse events from electrical muscle stimulation
    The severity of pain related from electrical muscle stimulation by visual analog scale
    To determine the severity of pain related from electrical muscle stimulation by visual analog scale

    Full Information

    First Posted
    January 23, 2015
    Last Updated
    February 23, 2015
    Sponsor
    Chulalongkorn University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02370108
    Brief Title
    The Study of Rest Tremor Suppression by Using Electrical Muscle Stimulation
    Official Title
    The Study of Rest Tremor Suppression by Using Electrical Muscle Stimulation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 2015 (undefined)
    Primary Completion Date
    January 2016 (Anticipated)
    Study Completion Date
    May 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Chulalongkorn University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    Detailed Description
    Study method as follows: All subjects will be provided the information on this research study and informed consent will be sought for every subjects. All subjects (30 PD patients and 30 others tremor patients) will be interviewed by a movement disorders specialist or a trained interviewer for their demographic and clinical data. All PD patients will be examined for the severity of Parkinson's disease by a movement disorders specialist according the Unified Parkinson's disease Rating Scale (UPDRS), Hoehn and Yahr score, and tremor rating scale, during the 'on period' in order to determine the additional effect of EMS for suppression of tremor. Physical examinations of each patient will be recorded by the video recording for later reviewed. All essential tremor and dystonic tremor patients will be examined by a movement disorders specialist for the tremor severity according to the Fahn, Tolosa, Marin Tremor Rating Scale. Physical examinations of each patient will be recorded by the video recording for later reviewed. All patient will be determined for feasibility to use EMS and safety of EMS. Pain will determined by visual analog scale. All patients will be monitored their hand tremor at resting position and postural position. The tremor analysis with accelerometer and gyroscope system (Parkinson Monitor V0.006 Beta) and the surface EMG (Nicolet EDX Viking) will be conducted. The surface EMG electrode will place over thenar muscle of the hand, which is the most predominant sided of tremor, for quantitative measurement and determination of tremor physiology. All participants data from surface EMG will be applied to The Matlab™ program (MathWorks Inc.) in order to modify the qualitative signals into quantitative parameters and performing the high-dimensional feature vectors, and later to determine the different efficacy in pulse amplitude of electrical muscle stimulation on feature vectors. The electrical muscle stimulation (Intensity™ Twin Stim® III) will be conducted by placement the 2 self-adhesive electrode (size 1.5 inches * 1.5 inches) over thenar muscle and 1st&2nd interrosseous muscle of the hand, which is the most predominant sided of tremor. The EMS will be stimulated PD patients on the rest position, whereas the other tremors patients in both rest position and postural position. The pulse amplitude will be slowly titration until provided the tetanic muscle contraction (motor threshold) without pain (all applied frequency is 50 Hz). All of examination will be taken for 30 minutes for each one subject. Data Collection Demographic and clinical data: age, gender, clinical diagnosis, disease's duration and severity score for each subject according to establishing standard rating scale. Tremor parameters form Parkinson Monitor V0.006 Beta will be collected in both before and during EMS as 5 parameters: Peak magnitude, RMS, Angle, Frequency, Q The pulse amplitude from EMS will be recorded in every titration in order to determine the efficacy of EMS in difference pulse amplitude. The surface EMG and acceleration signal in difference pulse amplitude will be extracted and clustered data in order to analyze by using Matlab™, and performed the high-dimensional feature vectors for quantitative interpretation. Data Analysis The statistical analysis in this study is based from SPSS program version 17. Categorical data will be analyzed for frequency and percentage. Continuous data will be analyzed by mean and standard deviation (SD). Non-parametric study would be preferred if the small sample size or in case of distribution of data do not present as normal distribution (determined by Kolmogorov-Smirnov test). The repeated ANOVA will be used for determined the efficacy of difference pulse amplitude on tremor suppression and the efficacy of EMS in the difference times in follow up periods.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rest Tremor, Parkinson's Disease
    Keywords
    electrical muscle stimulation, parkinson's disease, rest tremor, tremor reduction

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    PD patient
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    OT patients
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    electrical muscle stimulation
    Intervention Description
    electrical muscle stimulation at hand muscle for reduction tremor
    Primary Outcome Measure Information:
    Title
    Number of participant who had tremor suppression determine by reduction of tremor rating scale during electrical muscle stimulation
    Description
    To determine the number of participant with tremor suppression during electrical muscle stimulation
    Time Frame
    up to 1 month follow up
    Secondary Outcome Measure Information:
    Title
    Number of participant who report pain or any adverse events from electrical muscle stimulation
    Description
    To determine number of participant who report pain or adverse events from electrical muscle stimulation
    Time Frame
    up to 1 month follow up
    Title
    The severity of pain related from electrical muscle stimulation by visual analog scale
    Description
    To determine the severity of pain related from electrical muscle stimulation by visual analog scale
    Time Frame
    intraoperative

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Onanong Jitkritsadakul, MD, MSc
    Phone
    0863570212
    Email
    onanong.jit@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Roongroj Bhidayasiri, MD, FRCP
    Phone
    022564630
    Email
    rbh1@ucla.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Roongroj Bhidayasiri, MD, FRCP
    Organizational Affiliation
    Chulalongkorn University
    Official's Role
    Study Director

    12. IPD Sharing Statement

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