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

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

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 Overview

• Status: Unknown
• Conditions: Parkinson's Disease
• Intervention / Treatment: Device: Parkinson's glove; Device: sham glove

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
• Enrollment (Anticipated): 50
• Phase: Phase 1

Contacts and Locations

Study Locations

• Thailand
  • Bangkok
    • Pathumwan, Bangkok, Thailand, 10330
      • Chulalongkorn University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants who demonstrate the tremor suppression after use parkinson's glove	To determine the tremor suppression after use the parkinson's glove by the tremor rating scale	up to 1 month follow up period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants who report pain or any adverse events from parkinson's glove	To determine the safety of parkinson's glove	14 days periods of using parkinson's glove and in subsequent 1 month follow up period
Determine the severity of pain related with parkinson's glove	To determine the severity of pain by visual analog scale	14 days periods of using parkinson's glove

Collaborators and Investigators

• Sponsor: Chulalongkorn University
• Investigators: Study Director: Roongroj Bhidayasiri, MD, FRCP, Chulalongkorn University

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Anticipated): January 1, 2016
• Study Completion (Anticipated): May 1, 2017

Study Registration Dates

• First Submitted: January 15, 2015
• First Submitted That Met QC Criteria: February 23, 2015
• First Posted (Estimate): February 24, 2015

Study Record Updates

• Last Update Posted (Estimate): February 24, 2015
• Last Update Submitted That Met QC Criteria: February 23, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Dyskinesias; Parkinson Disease; Tremor
• Other Study ID Numbers: 005/58