Parkinson's DiseaseNCT02768896
Monitoring Brain Waves in Response to Visual and/or Auditory Stimulation in Parkinson's Disease Patients
A study testing Baseline, visual stimuli and Auditory stimuli in people with Parkinson's Disease, run by Rambam Health Care Campus.
Trial summary
Voltage fluctuation as a result of brain activity will be recorded into the computer using an EEG device. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Baseline, visual stimuli and Auditory stimuli
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Feb 2018
- Phase
- Interventional
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Parkinson's disease that are ambulatory and can sign a written informed consent
Who cannot join
- Patients with Parkinson's disease who are not ambulatory
- Patients with dementia
- Patients that are blind
- Patients that have severe hearing impairment
Trial locations and contacts
No sites are listed yet.
Ilana Schlesinger, MD contact
About this study
Voltage fluctuation as a result of brain activity will be recorded into the computer using an EEG device.
Read the detailed description
Patients with Parkinson's disease may have gait disturbances including freezing of gait. Visual and auditory stimuli may improve gait. Investigators will analyze brain wave during walking while giving the subject different stimuli.
The voltage fluctuation (in hundreds of microvolts) will be recorded using the EEG cap and amplifier into a computer.
- Conditions
- Parkinson's Disease
- Being tested
- Baseline, visual stimuli, Auditory stimuli, Visual and auditory stimuli
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BaselineBehavioural
Patients will walk naturally with EEG measuring brain waves
visual stimuliBehavioural
Patients will walk naturally with EEG measuring brain waves while seeing a grid through glasses
Auditory stimuliBehavioural
Patients will walk naturally with EEG measuring brain waves while hearing an auditory stimuli
Visual and auditory stimuliBehavioural
Patients will walk naturally with EEG measuring brain waves while seeing a grid through glasses and hearing an auditory stimuli simultaneously
| Study group | Role | What they receive |
|---|---|---|
| Baseline | No intervention | Patients will walk naturally with EEG measuring brain waves |
| Visual stimuli | Experimental | Patients will walk naturally with EEG measuring brain waves while seeing a grid through glasses Receives: Behavioral: Baseline; Behavioral: visual stimuli |
| Auditory stimuli | Experimental | Patients will walk naturally with EEG measuring brain waves while hearing an auditory stimuli Receives: Behavioral: Baseline; Behavioral: Auditory stimuli |
| Visual and auditory stimuli | Experimental | Patients will walk naturally with EEG measuring brain waves while seeing a grid through glasses and hearing an auditory stimuli simultaneously Receives: Behavioral: Baseline; Behavioral: Visual and auditory stimuli |
What is being measured
The primary outcome is the main question the study is designed to answer.
Voltage fluctuation resulting from brain activity after visual stimuli
Change in brain wave activity after visual stimuli as compared with baseline measured in tens of micro-volts per second.
Measured: One hour
Voltage fluctuation resulting from brain activity after auditory stimuli
Change in brain wave activity after auditory stimuli as compared with baseline measured in tens of micro-volts per second.
Measured: One hour
Voltage fluctuation resulting from brain activity after visual and auditory stimuli
Change in brain wave activity after visual and auditory stimuli as compared with baseline measured in tens of micro-volts per second.
Measured: One hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2016 (estimated)
- Study startJun 2016
- Primary completionJan 2018 (estimated)
- Study completionFeb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's 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
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Collaborators
- Technion, Israel Institute of Technology
- Responsible party
- Sponsor
- Investigators
- Ilana Schlesinger, MD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02768896
- Sponsor's protocol ID
- 0182-16RMB
- Status last verified
- Jun 2016
- First submitted
- 4 Apr 2016
- Last updated
- 7 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Brain Waves in Response to Visual and/or Auditory Stimulation in Parkinson's Disease Patients
- ClinicalTrials.gov ID
- NCT02768896
- Acronym / sponsor ID
- 0182-16RMB
- Conditions
- Parkinson's Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Collaborators
- Technion, Israel Institute of Technology
- Study start
- Jun 2016
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 11 May 2016 (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.
Voltage fluctuation as a result of brain activity will be recorded into the computer using an EEG device.
Detailed description
Patients with Parkinson's disease may have gait disturbances including freezing of gait. Visual and auditory stimuli may improve gait. Investigators will analyze brain wave during walking while giving the subject different stimuli.
The voltage fluctuation (in hundreds of microvolts) will be recorded using the EEG cap and amplifier into a computer.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Baseline | No intervention | –Patients will walk naturally with EEG measuring brain waves |
| Visual stimuli | Experimental | Behavioral: Baseline, Behavioral: visual stimuliPatients will walk naturally with EEG measuring brain waves while seeing a grid through glasses |
| Auditory stimuli | Experimental | Behavioral: Baseline, Behavioral: Auditory stimuliPatients will walk naturally with EEG measuring brain waves while hearing an auditory stimuli |
| Visual and auditory stimuli | Experimental | Behavioral: Baseline, Behavioral: Visual and auditory stimuliPatients will walk naturally with EEG measuring brain waves while seeing a grid through glasses and hearing an auditory stimuli simultaneously |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with Parkinson's disease that are ambulatory and can sign a written informed consent
Key exclusion criteria (4 listed)
- Patients with Parkinson's disease who are not ambulatory
- Patients with dementia
- Patients that are blind
- Patients that have severe hearing impairment
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 |
|---|---|---|
| BaselinePatients will walk naturally with EEG measuring brain waves | Behavioural | Auditory stimuli, Visual and auditory stimuli, Visual stimuli |
| visual stimuliPatients will walk naturally with EEG measuring brain waves while seeing a grid through glasses | Behavioural | Visual stimuli |
| Auditory stimuliPatients will walk naturally with EEG measuring brain waves while hearing an auditory stimuli | Behavioural | Auditory stimuli |
| Visual and auditory stimuliPatients will walk naturally with EEG measuring brain waves while seeing a grid through glasses and hearing an auditory stimuli simultaneously | Behavioural | Visual and auditory stimuli |
Primary outcome
Voltage fluctuation resulting from brain activity after visual stimuli
Time frame: One hour
Change in brain wave activity after visual stimuli as compared with baseline measured in tens of micro-volts per second.
Voltage fluctuation resulting from brain activity after auditory stimuli
Time frame: One hour
Change in brain wave activity after auditory stimuli as compared with baseline measured in tens of micro-volts per second.
Voltage fluctuation resulting from brain activity after visual and auditory stimuli
Time frame: One hour
Change in brain wave activity after visual and auditory stimuli as compared with baseline measured in tens of micro-volts per second.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2016.
- 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.
Ilana Schlesinger, MD contact
Ilana Schlesinger, MD principal investigator
Rambam Health Care Campus
Questions about this trial
What is this clinical trial studying?
A study testing Baseline, visual stimuli and Auditory stimuli in people with Parkinson's Disease, run by Rambam Health Care Campus.
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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 7 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ilana Schlesinger, MD (972502062529), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Voltage fluctuation resulting from brain activity after visual stimuli (time frame: One hour). The study lists 3 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 7 Jun 2016.