Parkinson DiseaseEarly Phase 1BESTNCT03014050
Bio Electro Stimulation Therapy for Parkinson's Disease
A Early Phase 1 study testing e-Tapper TT-R1 in people with Parkinson Disease, run by Boston University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- e-Tapper TT-R1
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2017to 1 Jun 2019
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 12Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston University School of Medicine
Boston, Massachusetts, 02118
About this study
Official title: Effectiveness of Bio-Electro Stimulation Therapy for the Treatment of Motor and Non-Motor Symptoms in Parkinson's Disease - A Pilot Study
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.
Read the detailed 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.
- Conditions
- Parkinson Disease
- Being tested
- e-Tapper TT-R1
- Keywords
- physical activity, fitness, cognition, mood, depression, anxiety, sleep quality, tremor, gait
- Medical subject headings
- Parkinson Disease, Motor Activity, Depression, Anxiety Disorders, Sleep Initiation and Maintenance Disorders, Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
e-Tapper TT-R1Device
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.
| Study group | Role | What they receive |
|---|---|---|
| EH: Stimulation of Head Point | Experimental | Electrical stimulation of the head point of the hand (EH, experimental stimulation); intervention with e-Tapper TT-R1 Receives: 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 Receives: Device: e-Tapper TT-R1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity
Assessment of physical activity with body-worn sensor
Measured: 10-12 weeks
Visuospatial Cognition
Assessment of visuospatial cognition
Measured: 10-12 weeks
Mood
Mood will be assessed with questionnaires.
Measured: 10-12 weeks
Sleep quality
Sleep quality will be assessed with a questionnaire.
Measured: 10-12 weeks
Resting tremor
Resting tremor will be assessed with body-worn sensors.
Measured: 10-12 weeks
Gait
Gait will be assessed with body-worn sensors.
Measured: 10-12 weeks
Secondary outcomes (7)
Perceived pain
Perceived pain will be assessed with a questionnaire.
Measured: 10-12 weeks
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).
Measured: 10-12 weeks
Physical activity - Other
Subjective physical activity will be assessed with a questionnaire.
Measured: 10-12 weeks
Functional Fitness
Participants will undergo short field tests of functional fitness.
Measured: 10-12 weeks
Cognition - Language
Assessment of verbal fluency
Measured: 10-12 weeks
Cognition - Cognitive Control
Assessment of executive functions
Measured: 10-12 weeks
Cognition - learning and memory
Assessment of learning and memory
Measured: 10-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2017 (estimated)
- Study start22 Sep 2017
- Primary completion1 Jun 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karin Schon, Boston University
- Investigators
- Karin Schon, Ph.D., Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03014050
- Sponsor's protocol ID
- H-34609
- Other IDs
- BEST-PD2017
- Acronym
- BEST
- Status last verified
- Apr 2020
- First submitted
- 12 Dec 2016
- Last updated
- 3 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Bio-Electro Stimulation Therapy for the Treatment of Motor and Non-Motor Symptoms in Parkinson's Disease - A Pilot Study
- ClinicalTrials.gov ID
- NCT03014050
- Acronym / sponsor ID
- BEST / H-34609
- Conditions
- Parkinson Disease
- Keywords
- physical activity, fitness, cognition, mood, depression, anxiety, sleep quality, tremor
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Study start
- 22 Sep 2017 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 9 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EH: Stimulation of Head Point | Experimental | Device: e-Tapper TT-R1Electrical stimulation of the head point of the hand (EH, experimental stimulation); intervention with e-Tapper TT-R1 |
| CS: Control Stimulation | Active comparator | Device: e-Tapper TT-R1Electrical stimulation of the leg point of the hand (CS, control stimulation); intervention with e-Tapper TT-R1 |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| e-Tapper TT-R1The 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. | Device | CS: Control Stimulation, EH: Stimulation of Head Point |
Primary outcome
Physical activity
Time frame: 10-12 weeks
Assessment of physical activity with body-worn sensor
Visuospatial Cognition
Time frame: 10-12 weeks
Assessment of visuospatial cognition
Mood
Time frame: 10-12 weeks
Mood will be assessed with questionnaires.
Sleep quality
Time frame: 10-12 weeks
Sleep quality will be assessed with a questionnaire.
Resting tremor
Time frame: 10-12 weeks
Resting tremor will be assessed with body-worn sensors.
Gait
Time frame: 10-12 weeks
Gait will be assessed with body-worn sensors.
7 secondary outcomes
Perceived pain
Time frame: 10-12 weeks
Quality of life and subjective health status
Time frame: 10-12 weeks
Physical activity - Other
Time frame: 10-12 weeks
Functional Fitness
Time frame: 10-12 weeks
Cognition - Language
Time frame: 10-12 weeks
Cognition - Cognitive Control
Time frame: 10-12 weeks
Cognition - learning and memory
Time frame: 10-12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karin Schon, Ph.D. principal investigator
Boston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing e-Tapper TT-R1 in people with Parkinson Disease, run by Boston University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity (time frame: 10-12 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2020.