Boost Study 21270 (Cognition)

NXTech

Status and phase: Completed; Early Phase 1

Conditions: Cognitive Function Abnormal

Treatments: Behavioral: mHealth application (custom)

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT05990335

R43DA051270 (U.S. NIH Grant/Contract)

NX-21270

Details and patient eligibility

About

This study is designed to to test the technical feasibility of encouraging interaction with a mobile smartphone software package (mHealth app) for training aspects of executive function and cognition.

Full description

The purpose of this human subjects study is to test the technical feasibility of interaction with a mobile smartphone software package (mHealth app) for training in aspects of executive function and cognition. The study participants are healthy subjects recruited online, with consent secured at the time of screening, and with enrollees assigned to High or Low groups on the basis of initial screening task scores. Subjects are requested to participate in directed interaction activities for up to 8 weeks, with measures primarily evaluating feasibility of MHealth app package task completion and secondarily evaluating the cognitive effect of activities.

Enrollment: 124 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 18 years and above
• Fluent in English
• Resides in the United States
• Score on prescreen task is in 25% quartile
• Familiar with smartphone device app installation and device usage
• Possesses a compatible smartphone

Exclusion criteria

None

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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124 participants in 2 patient groups

Cognition exercises group I

Experimental group

Description:

Subjects enrolled in this arm are exposed to an active task intervention designed for higher cognitive effort training functions

Treatment:

Behavioral: mHealth application (custom)

Cognition exercises group C

Active Comparator group

Description:

Subjects enrolled in this arm are exposed to an active task intervention designed for lower cognitive effort training functions

Treatment:

Behavioral: mHealth application (custom)