The Study of Rest Tremor Suppression by Using Electrical Muscle Stimulation

NCT02370108 | Unknown Phase 1 DMC

• 1 other identifier: 483/57
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is aimed to study the safety and feasibility of electrical muscle stimulation (EMS) in suppression of tremor from various causes especially for rest tremor in Parkinson's disease.

Conditions

Rest Tremor; Parkinson's Disease

Keywords

electrical muscle stimulation; parkinson's disease; rest tremor; tremor reduction

Outcome Measures

Primary Outcomes (1)

• Number of participant who had tremor suppression determine by reduction of tremor rating scale during electrical muscle stimulation

  To determine the number of participant with tremor suppression during electrical muscle stimulation

  up to 1 month follow up

Secondary Outcomes (2)

• Number of participant who report pain or any adverse events from electrical muscle stimulation

  up to 1 month follow up

• The severity of pain related from electrical muscle stimulation by visual analog scale

  intraoperative

Study Arms (2)

PD patient

EXPERIMENTAL

Parkinson's disease patients will get the electrical muscle stimulation at the most tremulous hand at 50 Hz frequency, maximal tolerate pulse amplitude (not over 20 mA), duration of stimulation for 10 second.

Device: electrical muscle stimulation

OT patients

EXPERIMENTAL

others tremor patients will get the electrical muscle stimulation at the most tremulous hand at 50 Hz frequency, maximal tolerate pulse amplitude (not over 20 mA), duration of stimulation for 10 second.

Device: electrical muscle stimulation

Interventions

electrical muscle stimulation DEVICE

electrical muscle stimulation at hand muscle for reduction tremor

OT patients; PD patient

Eligibility Criteria

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

You may qualify if:

• For PD patients
• 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 For other tremor patients
• Adults ≥ 18 years old.
• Patients with essential tremor diagnosed according to the TRIG criteria for essential tremor or patients with dystonic tremor diagnosed according to the proposed definition in which their symptoms shared similar trait of medically intractable tremor.
• Informed consent

You may not qualify if:

• For PD patients
• 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.
• For other tremor patients
• 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

MeSH Terms

Conditions

Tremor; Parkinson Disease

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central 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: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 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