Bio Electro Stimulation Therapy for Parkinson's Disease

NCT03014050 | Completed Early Phase 1 FDA Device

• 2 other identifiers: H-34609BEST-PD2017
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson Disease

Keywords

physical activity; fitness; cognition; mood; depression; anxiety; sleep quality; tremor; gait

Outcome Measures

Primary Outcomes (6)

• Physical activity

  Assessment of physical activity with body-worn sensor

  10-12 weeks

• Visuospatial Cognition

  Assessment of visuospatial cognition

  10-12 weeks

• Mood

  Mood will be assessed with questionnaires.

  10-12 weeks

• Sleep quality

  Sleep quality will be assessed with a questionnaire.

  10-12 weeks

• Resting tremor

  Resting tremor will be assessed with body-worn sensors.

  10-12 weeks

• Gait

  Gait will be assessed with body-worn sensors.

  10-12 weeks

Secondary Outcomes (7)

• Perceived pain

  10-12 weeks

• Quality of life and subjective health status

  10-12 weeks

• Physical activity - Other

  10-12 weeks

• Functional Fitness

  10-12 weeks

• Cognition - Language

  10-12 weeks

Study Arms (2)

EH: Stimulation of Head Point

EXPERIMENTAL

Electrical stimulation of the head point of the hand (EH, experimental stimulation); intervention with e-Tapper TT-R1

Device: e-Tapper TT-R1

CS: Control Stimulation

ACTIVE COMPARATOR

Electrical stimulation of the leg point of the hand (CS, control stimulation); intervention with e-Tapper TT-R1

Device: e-Tapper TT-R1

Interventions

e-Tapper TT-R1 DEVICE

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.

CS: Control Stimulation; EH: Stimulation of Head Point

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boston University: lead

Study Sites (1)

Boston University School of Medicine

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Motor Activity; Depression; Anxiety Disorders; Sleep Initiation and Maintenance Disorders; Tremor

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavior; Behavioral Symptoms; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Karin Schon, Ph.D.

  Boston University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Anatomy & Neurobiology

Study Record Dates

• First Submitted: December 12, 2016
• First Posted: January 9, 2017
• Study Start: September 22, 2017
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: April 3, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)