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Development of Parkinson's Glove for Detection and Suppression of Hand Tremor

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ClinicalTrials.gov Identifier: NCT02370134
Recruitment Status : Unknown
Verified February 2015 by Roongroj Bhidayasiri, 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):
Roongroj Bhidayasiri, Chulalongkorn University

Brief Summary:
This study is aimed to study the feasibility and safety of parkinson's glove that combined 2 module of tremor detection and tremor suppression with electrical muscle stimulation for using as device for rest tremor suppression in parkinson's disease patients

Condition or disease Intervention/treatment Phase
Parkinson's Disease Device: Parkinson's glove Device: sham glove Phase 1

Detailed Description:

Study Population

  1. Target: Thai Parkinson's disease (PD) patients with predominant rest tremor : 50 patients
  2. Population sample: Patients who are getting their treatment at the Chulalongkorn Comprehensive Movement Disorder Clinic at King Chulalongkorn Memorial Hospital.

Study methods as follows:

  • All PD subjects will be provided the information on this research study and informed consent will be sought for every subjects.
  • All PD subjects will be interviewed by a movememt 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 parkinson's glove and sham glove for suppression of tremor
  • All PD patients will be randomly allocated into 2 groups (25 Parkinson's glove and 25 sham glove) with block randomization method.
  • All patients will get Parkinson's glove for home-based usage for 14 days, the appointment for follow -up will be done for 4 times, with once daily phone call from investigators in order to check for improvement symptoms and all adverse events such as pain will be recorded and determined it severity by the visual analog scale.

Data collection

  • Demographic and clinical data: age, gender, clinical diagnosis, tremor rating scale, pain score by visual analog scale , Parkinson's disease's severity score for each subject according to establishing standard rating scale.
  • Tremor parameters form Parkinson's glove will be collected in SD card as 5 parameters: Peak magnitude, RMS, Angle, Frequency, Q. Number of stimulation times will be recorded.

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 parkinson's glove in the difference times in follow up periods.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Development of Parkinson's Glove for Detection and Suppression of Hand Tremor at Rest Among the Tremor-predominant Parkinson's Disease Patients With Medically Intractable Tremor
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: Parkinson's glove
Parkinson's glove 14 days use with 4 times follow-up
Device: Parkinson's glove
Parkinson's glove had module for detection tremor by gyroscope/acceleroscope and suppression rest hand tremor with electrical muscle stimulation

Placebo Comparator: sham glove
sham glove (with light and sound)14 days use with 4 times follow-up
Device: sham glove



Primary Outcome Measures :
  1. Number of participants who demonstrate the tremor suppression after use parkinson's glove [ Time Frame: up to 1 month follow up period ]
    To determine the tremor suppression after use the parkinson's glove by the tremor rating scale


Secondary Outcome Measures :
  1. Number of Participants who report pain or any adverse events from parkinson's glove [ Time Frame: 14 days periods of using parkinson's glove and in subsequent 1 month follow up period ]
    To determine the safety of parkinson's glove

  2. Determine the severity of pain related with parkinson's glove [ Time Frame: 14 days periods of using parkinson's glove ]
    To determine the severity of pain by visual analog scale



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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:

  • • 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

Exclusion Criteria:

  • 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): NCT02370134


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

Locations
Thailand
Chulalongkorn University Hospital Not yet recruiting
Pathumwan, Bangkok, Thailand, 10330
Contact: Roongroj Bhidayasiri, MD    +662 256 4630    rbh1@ucla.edu   
Principal Investigator: Roongroj Bhidayasiri, MD         
Sponsors and Collaborators
Chulalongkorn University
Investigators
Study Director: Roongroj Bhidayasiri, MD, FRCP Chulalongkorn University

Responsible Party: Roongroj Bhidayasiri, Comprehensive Movement Disorders Center, Chulalongkorn University
ClinicalTrials.gov Identifier: NCT02370134     History of Changes
Other Study ID Numbers: 005/58
First Posted: February 24, 2015    Key Record Dates
Last Update Posted: February 24, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
Parkinson Disease
Tremor
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Dyskinesias
Neurologic Manifestations
Signs and Symptoms