Cognitive ImpairmentNCT03622840
Impact of Individual Cognitive Remediation for Parkinson's Disease
A study testing Cognitive Remediation in people with Cognitive Impairment and Parkinson Disease, run by New York Institute of Technology at 1 site in United States.
Trial summary
This is an interventional clinical trial that will be conducted as a pilot project. Investigators hope to conduct the study to obtain at least 10 study completers. The plan is to screen 20 Parkinson's Disease (PD) patients attending the Academic Health Care Center (AHCC) at NYIT College of Osteopathic Medicine clinic… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Cognitive Impairment, Parkinson Disease
- What is being tested?
- Cognitive Remediation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jul 2018to 30 Oct 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must be between 40 and 75 years old (including both ages) at the time of study screening.
- Subjects must have a diagnosis of Parkinson's Disease by a physician.
- Subjects must demonstrate adequate decisional capacity, in the judgment of the consenting study staff member, to make a choice about participating in this research study.
- Subjects must have been clinically stable (non-acute) for 2 weeks prior to consent; in the judgment of the Investigator.
- Subjects with a cognition level between Impaired and Average (scaled score between 4-12 or Index Score between 70-110) based on TOMAL Cognitive assessment at Visit 1
- Subjects must have the visual, auditory, and motor capacity to use the intervention in the judgment of the Principal Investigator.
Who cannot join
- Subjects who are participating in a concurrent research study or another interventional clinical trial 30 days prior to consenting.
- Subjects having a history of mental retardation or pervasive developmental disorder; or other co-morbid neurological disorder (e.g., epilepsy.)
- Subjects who appear to be intoxicated or under the influence of a controlled substance on any day of assessment must be rescheduled and may be discontinued based upon the discretion of the investigator
- Subjects on medications that affect the cognition in the last 12 hours prior to the study visits that assess the cognitive functions
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Institute of Technology College of Osteopathic Medicine
Old Westbury, New York, 11568
About this study
This is an interventional clinical trial that will be conducted as a pilot project. Investigators hope to conduct the study to obtain at least 10 study completers.
The plan is to screen 20 Parkinson's Disease (PD) patients attending the Academic Health Care Center (AHCC) at NYIT College of Osteopathic Medicine clinic and enroll the eligible candidates based on the inclusion and exclusion criteria. Subjects will have 11 study visits over the 11-week period. Subjects cognition will be assessed using a paper-based Test of Memory and Learning (TOMAL) tool. The same tool will be used to asses and compare the cognition at baseline, and end study visits. The weekly 30-mins of cognitive remediation exercises will be done using the Brain. HQ cognitive remediation software.
- Conditions
- Cognitive Impairment, Parkinson Disease
- Being tested
- Cognitive Remediation
- Keywords
- Cognitive Remediation
- Medical subject headings
- Cognitive Dysfunction, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive RemediationBehavioural
Also called Brain.HQ
Weekly 30-45mins Cognitive Remediation Sessions over 11 weeks
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's disease patients with cognitive impairment | Other | Online cognitive remediation program. Receives: Behavioral: Cognitive Remediation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Test of Memory and Learning (TOMAL) score
Paper based memory and attention test administered at the beginning and end of the study
Measured: Baseline and 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start12 Jul 2018
- Primary completion30 Oct 2018
- Study completion30 Oct 2018
Why it stopped: Completed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York Institute of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anu Raj, Psy.D, Principal investigator, New York Institute of Technology College of Osteopathic Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03622840
- Sponsor's protocol ID
- BHS-1379
- Status last verified
- Jun 2019
- First submitted
- 20 Jun 2018
- Last updated
- 20 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Individual Cognitive Remediation for Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03622840
- Acronym / sponsor ID
- BHS-1379
- Conditions
- Cognitive Impairment, Parkinson Disease
- Keywords
- Cognitive Remediation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- New York Institute of TechnologyUniversity, hospital or other
- Study start
- 12 Jul 2018 (actual)
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 30 Oct 2018 (actual)
- First posted
- 9 Aug 2018 (actual)
- 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.
This is an interventional clinical trial that will be conducted as a pilot project. Investigators hope to conduct the study to obtain at least 10 study completers.
The plan is to screen 20 Parkinson's Disease (PD) patients attending the Academic Health Care Center (AHCC) at NYIT College of Osteopathic Medicine clinic and enroll the eligible candidates based on the inclusion and exclusion criteria. Subjects will have 11 study visits over the 11-week period. Subjects cognition will be assessed using a paper-based Test of Memory and Learning (TOMAL) tool. The same tool will be used to asses and compare the cognition at baseline, and end study visits. The weekly 30-mins of cognitive remediation exercises will be done using the Brain. HQ cognitive remediation software.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parkinson's disease patients with cognitive impairment | Other | Behavioral: Cognitive RemediationOnline cognitive remediation program. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects must be between 40 and 75 years old (including both ages) at the time of study screening.
- Subjects must have a diagnosis of Parkinson's Disease by a physician.
- Subjects must demonstrate adequate decisional capacity, in the judgment of the consenting study staff member, to make a choice about participating in this research study.
- Subjects must have been clinically stable (non-acute) for 2 weeks prior to consent; in the judgment of the Investigator.
- Subjects with a cognition level between Impaired and Average (scaled score between 4-12 or Index Score between 70-110) based on TOMAL Cognitive assessment at Visit 1
Key exclusion criteria (4 listed)
- Subjects who are participating in a concurrent research study or another interventional clinical trial 30 days prior to consenting.
- Subjects having a history of mental retardation or pervasive developmental disorder; or other co-morbid neurological disorder (e.g., epilepsy.)
- Subjects who appear to be intoxicated or under the influence of a controlled substance on any day of assessment must be rescheduled and may be discontinued based upon the discretion of the investigator
- Subjects on medications that affect the cognition in the last 12 hours prior to the study visits that assess the cognitive functions
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 |
|---|---|---|
| Cognitive RemediationAlso: Brain.HQWeekly 30-45mins Cognitive Remediation Sessions over 11 weeks | Behavioural | Parkinson's disease patients with cognitive impairment |
Primary outcome
Change of Test of Memory and Learning (TOMAL) score
Time frame: Baseline and 11 weeks
Paper based memory and attention test administered at the beginning and end of the study
Results and safety
The study was stopped early (reason given: Completed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2019.
- Individual participant dataSharing planned: Undecided
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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.
Anu Raj, Psy.D principal investigator
New York Institute of Technology College of Osteopathic Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Remediation in people with Cognitive Impairment and Parkinson Disease, run by New York Institute of Technology 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 6 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: stopped early, as of the sponsor's last update on 20 Jun 2019. 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.
Are results available for this study?
The study was stopped early (reason given: Completed). Results are not available in the source record.
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 of Test of Memory and Learning (TOMAL) score (time frame: Baseline and 11 weeks). 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 20 Jun 2019.