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
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
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
NCT ID
NCT02370108
First Posted
January 23, 2015
Last Updated
February 23, 2015
Sponsor
Chulalongkorn University
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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The Study of Rest Tremor Suppression by Using Electrical Muscle Stimulation
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