The Efficacy of a Remote Cognitive Remediation Therapy (CRT) Program on Parkinson's Disease

NCT ID: NCT04955275

Last Updated: 2022-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2022-04-01

Brief Summary

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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.

Detailed Description

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Conditions

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Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Parkinson's Disease Patients receiving Cognitive Remediation Therapy

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.

Group Type EXPERIMENTAL

Cognitive Remediation Therapy Program (BrainHQ)

Intervention Type OTHER

Brain HQ games involving training cognitive abilities like memory and attention, made up of adapting tasks or creating our own.

Parkinson's Disease Patients not receiving Cognitive Remediation Therapy

Parkinson's Disease Subjects will receive no intervention, but still undergo pre- and post-intervention RBANS and PDQ-39 scores.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Subjects must be currently enrolled in the Rock Steady Boxing Program at the Adele Smithers Parkinson's Disease Center.
2. Subjects must be between 40 and 85 years old (including both ages) at the time of study screening.
3. Subjects must have a diagnosis of Parkinson's disease by a physician.
4. Subjects must have a MOCA score of 20 or above.
5. 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.
6. Subjects must have been clinically stable for 2 weeks prior to consent; in the judgment of the Investigator.
7. Subjects must have the visual, auditory, and motor capacity to use the intervention in the judgment of the Principal Investigator.
8. Subjects must be technologically capable of utilizing a computer and navigating through the programs.
9. Subjects must be mechanically capable of utilizing a computer and computer mouse.

Exclusion Criteria

1. Subjects should not be participating in a concurrent research study or other interventional clinical trial 30 days prior to consenting.
2. Subjects should not have a history of mental retardation or pervasive developmental disorder; or other co-morbid neurological disorder (e.g., epilepsy.)
3. Subject is unable to physically use a computer or a computer mouse.
4. Subject is unable to or refuses to give consent.
Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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New York Institute of Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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New York Institute of Technology

Old Westbury, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 29557365 (View on PubMed)

Diez-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.

Reference Type BACKGROUND
PMID: 27757820 (View on PubMed)

Petersen 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.

Reference Type BACKGROUND
PMID: 24605806 (View on PubMed)

Gough 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.

Reference Type BACKGROUND
PMID: 32092069 (View on PubMed)

Milman 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.

Reference Type BACKGROUND
PMID: 24322063 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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BHS-1660

Identifier Type: -

Identifier Source: org_study_id

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