Parkinson DiseaseNCT04955275
The Efficacy of a Remote Cognitive Remediation Therapy (CRT) Program on Parkinson's Disease
A study testing Cognitive Remediation Therapy Program (BrainHQ) in people with Parkinson Disease, run by New York Institute of Technology at 1 site in United States.
Trial summary
Purpose/Goal: To determine if a remote computerized cognitive remediation program (CRT) can stabilize or improve cognitive functioning in a group of patients from the New York Institute of Technology Academic Health Care Center with Parkinson's disease (PD) after three months of intervention. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Cognitive Remediation Therapy Program (BrainHQ)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2021to 1 Apr 2022
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must be currently enrolled in the Rock Steady Boxing Program at the Adele Smithers Parkinson's Disease Center.
- Subjects must be between 40 and 85 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 have a MOCA score of 20 or above.
- 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 for 2 weeks prior to consent; in the judgment of the Investigator.
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- Subjects must have the visual, auditory, and motor capacity to use the intervention in the judgment of the Principal Investigator.
- Subjects must be technologically capable of utilizing a computer and navigating through the programs.
- Subjects must be mechanically capable of utilizing a computer and computer mouse.
Who cannot join
- Subjects should not be participating in a concurrent research study or other interventional clinical trial 30 days prior to consenting.
- Subjects should not have a history of mental retardation or pervasive developmental disorder; or other co-morbid neurological disorder (e.g., epilepsy.)
- Subject is unable to physically use a computer or a computer mouse.
- Subject is unable to or refuses to give consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Institute of Technology
Old Westbury, New York, 11568
About this study
Purpose/Goal: To determine if a remote computerized cognitive remediation program (CRT) can stabilize or improve cognitive functioning in a group of patients from the New York Institute of Technology Academic Health Care Center with Parkinson's disease (PD) after three months of intervention.
Hypothesis: Patients with PD who present with current cognitive deficits will show improvement in such deficits after three months of participation in a remotely supervised structured Cognitive Remediation Therapy Program (CRT) compared to control subjects with PD who receive treatment as usual.
Research design: Pilot study. Prospective randomized treatment and control comparison pre-post study.
- Conditions
- Parkinson Disease
- Being tested
- Cognitive Remediation Therapy Program (BrainHQ)
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Remediation Therapy Program (BrainHQ)Other
Brain HQ games involving training cognitive abilities like memory and attention, made up of adapting tasks or creating our own.
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's Disease Patients receiving Cognitive Remediation Therapy | Experimental | Parkinson's Disease Subjects will undergo 10 weeks of Brain HQ training, 2 times a week an hour at a time. Also patients pre- and post-intervention RBANS and PDQ-39 scores. Receives: Other: Cognitive Remediation Therapy Program (BrainHQ) |
| Parkinson's Disease Patients not receiving Cognitive Remediation Therapy | No intervention | Parkinson's Disease Subjects will receive no intervention, but still undergo pre- and post-intervention RBANS and PDQ-39 scores. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Pre-Intervention
A brief, individually administered test measuring attention, language, visuospatial/constructional abilities, and immediate and delayed memory.
Measured: Initially, before any intervention/start of study.
The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Post-Intervention
A brief, individually administered test measuring attention, language, visuospatial/constructional abilities, and immediate and delayed memory.
Measured: 10 weeks after intervention/completion of the study.
Parkinson's Disease Questionnaire (PDQ-39) Pre-Intervention
A test that assesses how often people affected by Parkinson's experience difficulties across 8 dimensions of daily living including relationships, social situations and communication.
Measured: Initially, before any intervention/start of study.
Parkinson's Disease Questionnaire (PDQ-39) Post-Intervention
A test that assesses how often people affected by Parkinson's experience difficulties across 8 dimensions of daily living including relationships, social situations and communication.
Measured: 10 weeks after intervention/completion of the study.
Montreal Cognitive Assessment (MOCA) Pre-Intervention Screening
A rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation.
Measured: Initially, before any intervention/start of study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start1 Jun 2021
- Primary completion1 Apr 2022
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York Institute of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04955275
- Sponsor's protocol ID
- BHS-1660
- Status last verified
- Oct 2022
- First submitted
- 17 Jun 2021
- Last updated
- 5 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Diez-Cirarda M, Ibarretxe-Bilbao N, Pena J, Ojeda N. Efficacy of cognitive rehabilitation in Parkinson's disease. Neural Regen Res. 2018 Feb;13(2):226-227. doi: 10.4103/1673-5374.226390. No abstract available.
PubMed 29557365Diez-Cirarda M, Ojeda N, Pena J, Cabrera-Zubizarreta A, Lucas-Jimenez O, Gomez-Esteban JC, Gomez-Beldarrain MA, Ibarretxe-Bilbao N. Increased brain connectivity and activation after cognitive rehabilitation in Parkinson's disease: a randomized controlled trial. Brain Imaging Behav. 2017 Dec;11(6):1640-1651. doi: 10.1007/s11682-016-9639-x.
PubMed 27757820Petersen RC, Caracciolo B, Brayne C, Gauthier S, Jelic V, Fratiglioni L. Mild cognitive impairment: a concept in evolution. J Intern Med. 2014 Mar;275(3):214-28. doi: 10.1111/joim.12190.
PubMed 24605806Gough N, Brkan L, Subramaniam P, Chiuccariello L, De Petrillo A, Mulsant BH, Bowie CR, Rajji TK. Feasibility of remotely supervised transcranial direct current stimulation and cognitive remediation: A systematic review. PLoS One. 2020 Feb 24;15(2):e0223029. doi: 10.1371/journal.pone.0223029. eCollection 2020.
PubMed 32092069Milman U, Atias H, Weiss A, Mirelman A, Hausdorff JM. Can cognitive remediation improve mobility in patients with Parkinson's disease? Findings from a 12 week pilot study. J Parkinsons Dis. 2014;4(1):37-44. doi: 10.3233/JPD-130321.
PubMed 24322063
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of a Remote Cognitive Remediation Therapy (CRT) Program on Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04955275
- Acronym / sponsor ID
- BHS-1660
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- New York Institute of TechnologyUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 8 Jul 2021 (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.
Purpose/Goal: To determine if a remote computerized cognitive remediation program (CRT) can stabilize or improve cognitive functioning in a group of patients from the New York Institute of Technology Academic Health Care Center with Parkinson's disease (PD) after three months of intervention.
Hypothesis: Patients with PD who present with current cognitive deficits will show improvement in such deficits after three months of participation in a remotely supervised structured Cognitive Remediation Therapy Program (CRT) compared to control subjects with PD who receive treatment as usual.
Research design: Pilot study. Prospective randomized treatment and control comparison pre-post study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parkinson's Disease Patients receiving Cognitive Remediation Therapy | Experimental | Other: Cognitive Remediation Therapy Program (BrainHQ)Parkinson's Disease Subjects will undergo 10 weeks of Brain HQ training, 2 times a week an hour at a time. Also patients pre- and post-intervention RBANS and PDQ-39 scores. |
| Parkinson's Disease Patients not receiving Cognitive Remediation Therapy | No intervention | –Parkinson's Disease Subjects will receive no intervention, but still undergo pre- and post-intervention RBANS and PDQ-39 scores. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects must be currently enrolled in the Rock Steady Boxing Program at the Adele Smithers Parkinson's Disease Center.
- Subjects must be between 40 and 85 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 have a MOCA score of 20 or above.
- 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.
Key exclusion criteria (4 listed)
- Subjects should not be participating in a concurrent research study or other interventional clinical trial 30 days prior to consenting.
- Subjects should not have a history of mental retardation or pervasive developmental disorder; or other co-morbid neurological disorder (e.g., epilepsy.)
- Subject is unable to physically use a computer or a computer mouse.
- Subject is unable to or refuses to give consent.
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 Remediation Therapy Program (BrainHQ)Brain HQ games involving training cognitive abilities like memory and attention, made up of adapting tasks or creating our own. | Other | Parkinson's Disease Patients receiving Cognitive Remediation Therapy |
Primary outcome
The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Pre-Intervention
Time frame: Initially, before any intervention/start of study.
A brief, individually administered test measuring attention, language, visuospatial/constructional abilities, and immediate and delayed memory.
The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Post-Intervention
Time frame: 10 weeks after intervention/completion of the study.
A brief, individually administered test measuring attention, language, visuospatial/constructional abilities, and immediate and delayed memory.
Parkinson's Disease Questionnaire (PDQ-39) Pre-Intervention
Time frame: Initially, before any intervention/start of study.
A test that assesses how often people affected by Parkinson's experience difficulties across 8 dimensions of daily living including relationships, social situations and communication.
Parkinson's Disease Questionnaire (PDQ-39) Post-Intervention
Time frame: 10 weeks after intervention/completion of the study.
A test that assesses how often people affected by Parkinson's experience difficulties across 8 dimensions of daily living including relationships, social situations and communication.
Montreal Cognitive Assessment (MOCA) Pre-Intervention Screening
Time frame: Initially, before any intervention/start of study.
A rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation.
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 5 Oct 2022.
- Background: PubMed 29557365Diez-Cirarda M, Ibarretxe-Bilbao N, Pena J, Ojeda N. Efficacy of cognitive rehabilitation in Parkinson's disease. Neural Regen Res. 2018 Feb;13(2):226-227. doi: 10.4103/1673-5374.226390. No abstract available.
- Background: PubMed 27757820Diez-Cirarda M, Ojeda N, Pena J, Cabrera-Zubizarreta A, Lucas-Jimenez O, Gomez-Esteban JC, Gomez-Beldarrain MA, Ibarretxe-Bilbao N. Increased brain connectivity and activation after cognitive rehabilitation in Parkinson's disease: a randomized controlled trial. Brain Imaging Behav. 2017 Dec;11(6):1640-1651. doi: 10.1007/s11682-016-9639-x.
- Background: PubMed 24605806Petersen RC, Caracciolo B, Brayne C, Gauthier S, Jelic V, Fratiglioni L. Mild cognitive impairment: a concept in evolution. J Intern Med. 2014 Mar;275(3):214-28. doi: 10.1111/joim.12190.
- Background: PubMed 32092069Gough N, Brkan L, Subramaniam P, Chiuccariello L, De Petrillo A, Mulsant BH, Bowie CR, Rajji TK. Feasibility of remotely supervised transcranial direct current stimulation and cognitive remediation: A systematic review. PLoS One. 2020 Feb 24;15(2):e0223029. doi: 10.1371/journal.pone.0223029. eCollection 2020.
- Background: PubMed 24322063Milman U, Atias H, Weiss A, Mirelman A, Hausdorff JM. Can cognitive remediation improve mobility in patients with Parkinson's disease? Findings from a 12 week pilot study. J Parkinsons Dis. 2014;4(1):37-44. doi: 10.3233/JPD-130321.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Therapy Program (BrainHQ) in people with 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 9 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: finished, as of the sponsor's last update on 5 Oct 2022. 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 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?
The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Pre-Intervention (time frame: Initially, before any intervention/start of study.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04955275, which also lists 5 linked publications.
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 5 Oct 2022.