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