Clinical trial NCT02370134: 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
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Parkinson's Disease
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2015-02-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of participants who demonstrate the tremor suppression after use parkinson's glove
timeFrame: up to 1 month follow up period
Secondary outcomes:
measure: Number of Participants who report pain or any adverse events from parkinson's glove
timeFrame: 14 days periods of using parkinson's glove and in subsequent 1 month follow up period
measure: Determine the severity of pain related with parkinson's glove
timeFrame: 14 days periods of using parkinson's glove
Other outcomes:
Locations:
city: Pathumwan
country: Thailand
facility: Chulalongkorn University Hospital
state: Bangkok
Study officials:
affiliation: Chulalongkorn University
name: Roongroj Bhidayasiri, MD, FRCP
role: STUDY_DIRECTOR
References: