Bio Electro Stimulation Therapy for Parkinson's Disease

Parkinson Disease Clinical Trial

— BEST  

Official title:

Effectiveness of Bio-Electro Stimulation Therapy for the Treatment of Motor and Non-Motor Symptoms in Parkinson's Disease - A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03014050
• Other study ID #: H-34609
• Secondary ID: BEST-PD2017
• Status: Completed
• Phase: Early Phase 1
• Start date: September 22, 2017
• Est. completion date: June 1, 2019

Study information

• Verified date: April 2020
• Source: Boston University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Parkinson's disease (PD) is a neurodegenerative disorder characterized by motor dysfunction and non-motor symptoms. Here, the investigators propose in a pilot device feasibility trial to examine whether "Bio Electro Stimulation Therapy" (B.E.S.T.) with a small, non-invasive, handheld electronic device designed to apply micro current stimulation to a person's hand can ameliorate some of the symptoms of PD.

Description:

Parkinson's disease (PD) is a neurodegenerative disorder characterized by motor dysfunction, cognitive impairment, and other non-motor symptoms. Here, we propose to use "Bio Electro Stimulation Therapy" (B.E.S.T.) using the "e-Tapper TT-R1"owned by Immumax International Co. Ltd., a Hong Kong based company. The "e-Tapper" is a non-invasive, handheld electronic device designed to apply micro current stimulation to a person's hand at specified points representing various body parts, such as the head, leg, or foot. This is one form of Bio Electro Stimulation Therapy, known as "11-point Hand Treatment System". The current delivered is less than one milliampere. Anecdotal evidence suggests that this micro current stimulation may reduce resting tremor, restore facial expressions, and improve ease of movement, mood, and sleep quality in patients with PD. Scientific evidence for the effectiveness of the B.E.S.T. Hand Therapy appears to be lacking in the English language (Western) literature. The goal of this pilot device feasibility study is to examine whether B.E.S.T. can increase physical activity and functional fitness, enhance cognition, improve mood and subjective sleep quality, and modulate resting tremor and gait parameters in PD patients over a 6-week period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: June 1, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

Inclusion Criteria:

• High functioning without presence of cognitive impairment or dementia

• Native-English speaker or fluent in English

• Diagnosis of Parkinson's disease (Hoehn & Yahr stages I-III)

Exclusion Criteria:

• Implanted medical devices, such as a pacemaker or defibrillator

• Prescription medication or other drugs that affect the brain (e.g. anti-depressants, anxiolytics), except prescription medication for the treatment of Parkinson's disease

• Poor vision that cannot be corrected with glasses or contact lenses

• Presence of musculoskeletal impairments (e.g. fractures, hemiplegia, chronic joint pain)

• Not being able to walk without assistance

• Diagnosis of dementia or mild cognitive impairment

• Diabetes mellitus

• Taking medications for diabetes mellitus

• Skin irritation, disease or wound on the hands

• Current heart conditions, such as congestive heart failure, tachycardia, or other arrhythmias

• History of heart attack

• Psychiatric or neurological disorders other than Parkinson's disease (e.g. Major Depressive Disorder, anxiety disorder, epilepsy)

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Device:
• e-Tapper TT-R1
The e-Tapper is a non-invasive, handheld electronic device designed to apply micro current stimulation to a person's hands at specified points representing various body parts, such as the head, leg, or foot. This is one form of "Bio-Electro Stimulation Therapy" known as the "11-point Hand Treatment System". The current delivered is less than one milliampere.

Locations

Country	Name	City	State
United States	Boston University School of Medicine	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical activity	Assessment of physical activity with body-worn sensor	10-12 weeks
Primary	Visuospatial Cognition	Assessment of visuospatial cognition	10-12 weeks
Primary	Mood	Mood will be assessed with questionnaires.	10-12 weeks
Primary	Sleep quality	Sleep quality will be assessed with a questionnaire.	10-12 weeks
Primary	Resting tremor	Resting tremor will be assessed with body-worn sensors.	10-12 weeks
Primary	Gait	Gait will be assessed with body-worn sensors.	10-12 weeks
Secondary	Perceived pain	Perceived pain will be assessed with a questionnaire.	10-12 weeks
Secondary	Quality of life and subjective health status	This questionnaire, called "The 39-Item Parkinson's Disease Questionnaire" (PDQ-39) assesses how often people with Parkinson's disease experience difficulties in their lives in several domains, including mobility, activities of daily living, emotional well-being, stigma, social support, perceived cognition, communication, and bodily discomfort. A "PDQ-39 Summary Index" score will be calculated. Scores range from 0 (best quality of life) to 100 (worst quality of life).	10-12 weeks
Secondary	Physical activity - Other	Subjective physical activity will be assessed with a questionnaire.	10-12 weeks
Secondary	Functional Fitness	Participants will undergo short field tests of functional fitness.	10-12 weeks
Secondary	Cognition - Language	Assessment of verbal fluency	10-12 weeks
Secondary	Cognition - Cognitive Control	Assessment of executive functions	10-12 weeks
Secondary	Cognition - learning and memory	Assessment of learning and memory	10-12 weeks