Rest TremorPhase 1NCT02370108
The Study of Rest Tremor Suppression by Using Electrical Muscle Stimulation
A Phase 1 study testing electrical muscle stimulation in people with Rest Tremor and Parkinson's Disease, run by Chulalongkorn University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rest Tremor, Parkinson's Disease
- What is being tested?
- electrical muscle stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to May 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Rest Tremor, Parkinson's Disease
- Being tested
- electrical muscle stimulation
- Keywords
- electrical muscle stimulation, parkinson's disease, rest tremor, tremor reduction
- Medical subject headings
- Tremor, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electrical muscle stimulationDevice
electrical muscle stimulation at hand muscle for reduction tremor
| Study group | Role | What they receive |
|---|---|---|
| PD patient | Experimental | 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. Receives: Device: electrical muscle stimulation |
| OT patients | Experimental | 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. Receives: Device: electrical muscle stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 1 month follow up
Secondary outcomes (2)
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
Measured: up to 1 month follow up
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
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionJan 2016 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rest TremorStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roongroj Bhidayasiri, MD, FRCP, Study director, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02370108
- Sponsor's protocol ID
- 483/57
- Status last verified
- Feb 2015
- First submitted
- 23 Jan 2015
- Last updated
- 24 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Rest Tremor Suppression by Using Electrical Muscle Stimulation
- ClinicalTrials.gov ID
- NCT02370108
- Acronym / sponsor ID
- 483/57
- Conditions
- Rest Tremor, Parkinson's Disease
- Keywords
- electrical muscle stimulation, parkinson's disease, rest tremor, tremor reduction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Jan 2016 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 24 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PD patient | Experimental | Device: electrical muscle stimulationParkinson'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. |
| OT patients | Experimental | Device: electrical muscle stimulationothers 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- For PD patients
Key exclusion criteria (8 listed)
- For PD patients
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electrical muscle stimulationelectrical muscle stimulation at hand muscle for reduction tremor | Device | OT patients, PD patient |
Primary outcome
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
2 secondary outcomes
Number of participant who report pain or any adverse events from electrical muscle stimulation
Time frame: up to 1 month follow up
The severity of pain related from electrical muscle stimulation by visual analog scale
Time frame: intraoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roongroj Bhidayasiri, MD, FRCP study director
Chulalongkorn University
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing electrical muscle stimulation in people with Rest Tremor and Parkinson's Disease, run by Chulalongkorn University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Onanong Jitkritsadakul, MD, MSc (0863570212, onanong.jit@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2015.