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

NCT ID: NCT02370134

Last Updated: 2015-02-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2017-05-31

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

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.

Conditions

Parkinson's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Parkinson's glove

Parkinson's glove 14 days use with 4 times follow-up

Group Type: EXPERIMENTAL

Parkinson's glove

Intervention Type: DEVICE

Parkinson's glove had module for detection tremor by gyroscope/acceleroscope and suppression rest hand tremor with electrical muscle stimulation

sham glove

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

Group Type: PLACEBO_COMPARATOR

sham glove

Intervention Type: DEVICE

Interventions

Parkinson's glove

Parkinson's glove had module for detection tremor by gyroscope/acceleroscope and suppression rest hand tremor with electrical muscle stimulation

Intervention Type: DEVICE

sham glove

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chulalongkorn University

OTHER

Sponsor Role: lead

Responsible Party

Roongroj Bhidayasiri

Comprehensive Movement Disorders Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Roongroj Bhidayasiri, MD, FRCP

Role: STUDY_DIRECTOR

Chulalongkorn University

Locations

Chulalongkorn University Hospital

Pathumwan, Bangkok, Thailand

Countries

Thailand

Central Contacts

Onanong Jitkritsadakul, MD, MSc

Role: CONTACT

onanong.jit@gmail.com

0863570212

Roongroj Bhidayasiri, MD, FRCP

Role: CONTACT

rbh1@ucla.com

022564630

Facility Contacts

Roongroj Bhidayasiri, MD

Role: primary

rbh1@ucla.edu

+662 256 4630

Other Identifiers

005/58

Identifier Type: -

Identifier Source: org_study_id