Parkinson's DiseaseNCT02922530
Piloting a Novel, Mobile Cognitive Tracking and Training Tool for Patients With Parkinson's Disease (PD)
A study testing Computerized Plasticity-based Adaptive Cognitive Training and Commercially available computerized training in people with Parkinson's Disease, run by Posit Science Corporation.
Trial summary
The overall goal of this research proposal is to develop an adjunct to standard treatments that 'correct' disrupted neural circuitry in Parkinson's Disease (PD) patients. Directly treating these core deficits via targeted behavioral training should slow the progression of PD, assure greater resilience against future… Read more about this study
- Who is it for?
- Ages 40 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Computerized Plasticity-based Adaptive Cognitive Training and Commercially available computerized training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to Feb 2017
- 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 40 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must meet diagnostic criteria for Parkinson's Disease with mild-to-moderate stage
- Participants must be fluent English speakers
- Participants must have the capability of completing the study as assessed by intact global cognition
- Participants must be able to engage with computerized cognitive tasks as required in the study
- Participants must have normal vision (or corrected to normal vision)
- Participants must have adequate hearing acuity
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- Participants must have the motor capacity to use an iPad or mobile device
- Participants must be willing to commit to the time requirements of the study
- Participants must obtain benefit on dopaminergic treatment (dopamine agonist or levodopa) and be on a stable dose for at least one month prior to screening
- Participant must have access to wireless internet connectivity
- Participant must have at least mild depression as assessed by Beck Depression Inventory (BDI-II)
Who cannot join
- Participants who are unable to perform neuropsychological assessments in the opinion of the evaluating staff person
- Participants who cannot comprehend or follow instructions, in the opinion of the consenting staff person
- Participants who are not capable of giving informed consent, in the opinion of the consenting staff person
- Participants who show signs of intoxication due to current substance abuse (including alcohol and/or illegal drugs) during any in person visit
- Participants with history of significant medical diseases or multiple neurological events of the head
- Participants with serious or unstable medical illness
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- Participants with history or current diagnosis of the following Diagnostic and Statistical Manual of Mental Disorders (DSM-5) psychiatric illness: organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorder not otherwise specific, bipolar disorder, substance dependence, substance abuse (< 1 year) (subjects with co-occurring post-traumatic stress disorder and related disorders are eligible for participation) as diagnosed through medical history
- Participants with history of seizure disorder
- Participants who are pregnant
- Participants who experience frequent falls (several times a week)
- Participants with severe dyskinesia
- Participants with active suicidal ideations or behaviors as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)
- Participants enrolled in a concurrent clinical trial involving an investigational pharmaceutical, nutraceutical, medical device, or behavioral treatment that could affect the outcome of this study
- Participant is using computer-based cognitive training programs or has used it within a month of the consent date
About this study
The overall goal of this research proposal is to develop an adjunct to standard treatments that 'correct' disrupted neural circuitry in Parkinson's Disease (PD) patients. Directly treating these core deficits via targeted behavioral training should slow the progression of PD, assure greater resilience against future decline, and improve the quality of life of many living with PD. The purpose of this exploratory research study is to determine the benefits, if any, of the mobile device-based treatment described above in individuals with PD.
- Conditions
- Parkinson's Disease
- Being tested
- Computerized Plasticity-based Adaptive Cognitive Training, Commercially available computerized training
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized Plasticity-based Adaptive Cognitive TrainingOther
Commercially available computerized trainingOther
| Study group | Role | What they receive |
|---|---|---|
| Experimental Treatment | Experimental | Computerized plasticity-based adaptive cognitive training requiring up to a maximum of 80 treatment sessions, up to 7 sessions per week, 15-60 minutes per session Receives: Other: Computerized Plasticity-based Adaptive Cognitive Training |
| Active Comparator | Active comparator | Commercially available computerized training requiring up to a maximum of 80 treatment sessions, up to 7 sessions per week, 15-60 minutes per session. Receives: Other: Commercially available computerized training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change scores for depressive symptoms using Beck Depression Scale (BDI-II)
Measured: At 3 months and 6 months
Change scores for Quality of Life using Parkinson's Disease Questionnaire (PDQ-39)
Measured: At 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2016 (estimated)
- Study startNov 2016
- Primary completionFeb 2017
- Study completionFeb 2017
Why it stopped: Principal Investigator departed for another position.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Posit Science Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alit Stark-Inbar, PhD, Principal investigator, Posit Science CorporationMouna Attarha, PhD, Principal investigator, Posit Science Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02922530
- Sponsor's protocol ID
- PSC-1010-16
- Status last verified
- Feb 2017
- First submitted
- 29 Sep 2016
- Last updated
- 23 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Piloting a Novel, Mobile Cognitive Tracking and Training Tool for Patients With Parkinson's Disease (PD)
- ClinicalTrials.gov ID
- NCT02922530
- Acronym / sponsor ID
- PSC-1010-16
- Conditions
- Parkinson's Disease
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Principal Investigator departed for another position.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Posit Science CorporationIndustry (pharma, biotech, devices)
- Study start
- Nov 2016
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 4 Oct 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.
The overall goal of this research proposal is to develop an adjunct to standard treatments that 'correct' disrupted neural circuitry in Parkinson's Disease (PD) patients. Directly treating these core deficits via targeted behavioral training should slow the progression of PD, assure greater resilience against future decline, and improve the quality of life of many living with PD. The purpose of this exploratory research study is to determine the benefits, if any, of the mobile device-based treatment described above in individuals with PD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Treatment | Experimental | Other: Computerized Plasticity-based Adaptive Cognitive TrainingComputerized plasticity-based adaptive cognitive training requiring up to a maximum of 80 treatment sessions, up to 7 sessions per week, 15-60 minutes per session |
| Active Comparator | Active comparator | Other: Commercially available computerized trainingCommercially available computerized training requiring up to a maximum of 80 treatment sessions, up to 7 sessions per week, 15-60 minutes per session. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Participants must meet diagnostic criteria for Parkinson's Disease with mild-to-moderate stage
- Participants must be fluent English speakers
- Participants must have the capability of completing the study as assessed by intact global cognition
- Participants must be able to engage with computerized cognitive tasks as required in the study
- Participants must have normal vision (or corrected to normal vision)
Key exclusion criteria (14 listed)
- Participants who are unable to perform neuropsychological assessments in the opinion of the evaluating staff person
- Participants who cannot comprehend or follow instructions, in the opinion of the consenting staff person
- Participants who are not capable of giving informed consent, in the opinion of the consenting staff person
- Participants who show signs of intoxication due to current substance abuse (including alcohol and/or illegal drugs) during any in person visit
- Participants with history of significant medical diseases or multiple neurological events of the head
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 |
|---|---|---|
| Computerized Plasticity-based Adaptive Cognitive Training | Other | Experimental Treatment |
| Commercially available computerized training | Other | Active Comparator |
Primary outcome
Change scores for depressive symptoms using Beck Depression Scale (BDI-II)
Time frame: At 3 months and 6 months
Change scores for Quality of Life using Parkinson's Disease Questionnaire (PDQ-39)
Time frame: At 3 months and 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
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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.
Alit Stark-Inbar, PhD principal investigator
Posit Science Corporation
Mouna Attarha, PhD principal investigator
Posit Science Corporation
Questions about this trial
What is this clinical trial studying?
A study testing Computerized Plasticity-based Adaptive Cognitive Training and Commercially available computerized training in people with Parkinson's Disease, run by Posit Science Corporation.
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 11 inclusion and 14 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: withdrawn, as of the sponsor's last update on 23 Feb 2017. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change scores for depressive symptoms using Beck Depression Scale (BDI-II) (time frame: At 3 months and 6 months). The study lists 2 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 23 Feb 2017.