Validation Study of a New Digital Treatment Test | NCT04897464

Studies
Validation Study of a New Digital Treatment Test

NCT04897464

Sponsor

Braingaze

Status

Unknown status

Last Update Posted

May 21, 2021Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Alzheimer Disease
MCI

Interventions

BGaze therapy Alzheimer

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2021Estimated

Primary Completion Date

Mar 31, 2022Estimated

Completion Date

May 31, 2022Estimated

First Submitted Date

May 13, 2021

First Submission Date that Met QC Criteria

May 18, 2021

First Posted Date

May 21, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 18, 2021

Last Update Posted Date

May 21, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Oculomotor behavior and cognitive processing of visual information are intimately connected. AD patients show ocular movement problems. Oculomotor deficits are broad consisting mainly of different saccade metrics, altered pupil responses. and smaller and irregular eye vergence movements. Here we test an interactive eye-tracking game to improve eye motion control and thereby training cognitive behavior

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment	Experimental		Other: BGaze therapy Alzheimer

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BGaze therapy Alzheimer	Other	BGaze Therapy is an interactive eye tracking game	Treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
MoCA	Measure changes in MoCA	immediately after the intervention
MMSE	Measure changes in MMSE	immediately after the intervention

Secondary Outcomes

Measure	Description	Time Frame
CANTAB	Measure changes in CANTAB tests	immediately after the intervention

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1) Clinical diagnosis of MCI or AD

Exclusion Criteria:

Severe cognitive deterioration
History of neurological disease with clinically relevant impact on cognition
Severe psychiatric disorder
Incidental structural brain findings with impact on cognitive impairment
Presence of relevant visual problems

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hans Super	Contact	0034931696572		hans@braingaze.eu
Laszlo Bax	Contact	0034931696572		Laszlo@braingaze.eu

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Braingaze	Recruiting	Mataró	Barcelona	08302	Spain

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

anonymized data can be shared upon request

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000544	Alzheimer Disease

Ancestor Terms

ID	Term
D003704	Dementia
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided