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

NCT02370134 | Unknown Phase 1 DMC

• 1 other identifier: 005/58
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of Participants who report pain or any adverse events from 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

  14 days periods of using parkinson's glove

Study Arms (2)

Parkinson's glove

EXPERIMENTAL

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

Device: Parkinson's glove

sham glove

PLACEBO COMPARATOR

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

Device: sham glove

Interventions

Parkinson's glove DEVICE

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

Parkinson's glove

sham glove DEVICE

sham glove

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chulalongkorn University: lead

Study Sites (1)

Chulalongkorn University Hospital

Pathumwan, Bangkok, 10330, Thailand

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Roongroj Bhidayasiri, MD, FRCP

  Chulalongkorn University

  STUDY DIRECTOR

Central Study Contacts

Onanong Jitkritsadakul, MD, MSc

CONTACT

0863570212; onanong.jit@gmail.com

Roongroj Bhidayasiri, MD, FRCP

CONTACT

022564630; rbh1@ucla.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Comprehensive Movement Disorders Center

Study Record Dates

• First Submitted: January 15, 2015
• First Posted: February 24, 2015
• Study Start: February 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: May 1, 2017
• Last Updated: February 24, 2015

Record last verified: 2015-02

Locations

TH (1)