Impact of Individual Cognitive Remediation for Parkinson's Disease

Impact of Individual Cognitive Remediation for Parkinson's Disease

Patrocinadores

Patrocinador principal: New York Institute of Technology

Fuente New York Institute of Technology
Resumen breve

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.

Estado general Terminated
Fecha de inicio July 12, 2018
Fecha de Terminación October 30, 2018
Fecha de finalización primaria October 30, 2018
Fase N/A
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Change of Test of Memory and Learning (TOMAL) score Baseline and 11 weeks
Inscripción 12
Condición
Intervención

Tipo de intervención: Behavioral

Nombre de intervención: Cognitive Remediation

Descripción: Weekly 30-45mins Cognitive Remediation Sessions over 11 weeks

Etiqueta de grupo de brazo: Parkinson's disease patients with cognitive impairment

Otro nombre: Brain.HQ

Elegibilidad

Criterios:

Inclusion Criteria:

1. Subjects must be between 40 and 75 years old (including both ages) at the time of study screening.

2. Subjects must have a diagnosis of Parkinson's Disease by a physician.

3. 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.

4. Subjects must have been clinically stable (non-acute) for 2 weeks prior to consent; in the judgment of the Investigator.

5. 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

6. Subjects must have the visual, auditory, and motor capacity to use the intervention in the judgment of the Principal Investigator.

Exclusion Criteria:

1. Subjects who are participating in a concurrent research study or another interventional clinical trial 30 days prior to consenting.

2. Subjects having a history of mental retardation or pervasive developmental disorder; or other co-morbid neurological disorder (e.g., epilepsy.)

3. 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

4. Subjects on medications that affect the cognition in the last 12 hours prior to the study visits that assess the cognitive functions

Género: All

Edad mínima: 40 Years

Edad máxima: 75 Years

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
Anu Raj, Psy.D Principal Investigator New York Institute of Technology College of Osteopathic Medicine
Ubicación
Instalaciones: New York Institute of Technology College of Osteopathic Medicine
Ubicacion Paises

United States

Fecha de verificación

June 2019

Fiesta responsable

Tipo: Sponsor

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 1
Grupo de brazo

Etiqueta: Parkinson's disease patients with cognitive impairment

Tipo: Other

Descripción: Online cognitive remediation program.

Datos del paciente Undecided
Información de diseño del estudio

Asignación: N/A

Modelo de intervención: Single Group Assignment

Propósito primario: Supportive Care

Enmascaramiento: None (Open Label)

Fuente: ClinicalTrials.gov