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

Primary Purpose

Parkinson's Disease

Status
Unknown status
Phase
Phase 1
Locations
Thailand
Study Type
Interventional
Intervention
Parkinson's glove
sham glove
Sponsored by
Chulalongkorn University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Chulalongkorn University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Parkinson's glove

sham glove

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of Participants who report pain or any adverse events from parkinson's glove
To determine the safety of parkinson's glove
Determine the severity of pain related with parkinson's glove
To determine the severity of pain by visual analog scale

Full Information

First Posted
January 15, 2015
Last Updated
February 23, 2015
Sponsor
Chulalongkorn University
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1. Study Identification

Unique Protocol Identification Number
NCT02370134
Brief Title
Development of Parkinson's Glove for Detection and Suppression of Hand Tremor
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 Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Unknown status
Study Start Date
February 2015 (undefined)
Primary Completion Date
January 2016 (Anticipated)
Study Completion Date
May 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chulalongkorn University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 Target: Thai Parkinson's disease (PD) patients with predominant rest tremor : 50 patients 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Parkinson's glove
Arm Type
Experimental
Arm Description
Parkinson's glove 14 days use with 4 times follow-up
Arm Title
sham glove
Arm Type
Placebo Comparator
Arm Description
sham glove (with light and sound)14 days use with 4 times follow-up
Intervention Type
Device
Intervention Name(s)
Parkinson's glove
Intervention Description
Parkinson's glove had module for detection tremor by gyroscope/acceleroscope and suppression rest hand tremor with electrical muscle stimulation
Intervention Type
Device
Intervention Name(s)
sham glove
Primary Outcome Measure Information:
Title
Number of participants who demonstrate the tremor suppression after use parkinson's glove
Description
To determine the tremor suppression after use the parkinson's glove by the tremor rating scale
Time Frame
up to 1 month follow up period
Secondary Outcome Measure Information:
Title
Number of Participants who report pain or any adverse events from parkinson's glove
Description
To determine the safety of parkinson's glove
Time Frame
14 days periods of using parkinson's glove and in subsequent 1 month follow up period
Title
Determine the severity of pain related with parkinson's glove
Description
To determine the severity of pain by visual analog scale
Time Frame
14 days periods of using parkinson's glove

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Onanong Jitkritsadakul, MD, MSc
Phone
0863570212
Email
onanong.jit@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Roongroj Bhidayasiri, MD, FRCP
Phone
022564630
Email
rbh1@ucla.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roongroj Bhidayasiri, MD, FRCP
Organizational Affiliation
Chulalongkorn University
Official's Role
Study Director
Facility Information:
Facility Name
Chulalongkorn University Hospital
City
Pathumwan
State/Province
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roongroj Bhidayasiri, MD
Phone
+662 256 4630
Email
rbh1@ucla.edu
First Name & Middle Initial & Last Name & Degree
Roongroj Bhidayasiri, MD

12. IPD Sharing Statement

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

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