Applying Neuromodulation to Accelerate Training Effects | NCT03224559

Studies
Applying Neuromodulation to Accelerate Training Effects

NCT03224559

Sponsor

University of Minnesota

Status

Withdrawn

Last Update Posted

Nov 12, 2019Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Cognition

Interventions

Transcranial Electrical Stimulation

Countries

United States

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

Nov 2019

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Enrollment never began.

Expanded Access Info

Start Date

Sep 1, 2019Estimated

Primary Completion Date

May 30, 2020Estimated

Completion Date

May 30, 2021Estimated

First Submitted Date

Jun 16, 2017

First Submission Date that Met QC Criteria

Jul 19, 2017

First Posted Date

Jul 21, 2017Actual

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

Nov 7, 2019

Last Update Posted Date

Nov 12, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study seeks to understand at how noninvasive electrical brain stimulation might change how people perform on on tasks requiring concentration and thinking skills.

Detailed Description

This study uses noninvasive electrical stimulation delivered through seeks to understand at how noninvasive electrical brain stimulation might change how people perform on on tasks requiring concentration and thinking skills.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sham Stimulation		subject receives minimal transcranial electrical stimulation	Device: Transcranial Electrical Stimulation
Left Side Stimulation		transcranial electrical stimulation on the left side of the head.	Device: Transcranial Electrical Stimulation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Transcranial Electrical Stimulation	Device	Transcranial Electrical Stimulation	Left Side Stimulation Sham Stimulation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Working memory	Working Memory	Baseline through 2 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

People may participate in the experiment if they have normal or corrected vision, are in good health, and are at least 18 years old.

Exclusion Criteria:

People will be screened and excluded from participation if they are currently ill or if they report any history of seizures, if they lack the capacity to consent or appear to lack capacity to consent, if they have participated in previous thinking skills training or brain stimulation, or if they are currently taking certain substances/medications that might change thinking skills.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Healthy volunteers, 18-65 years old

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Angus W MacDonald, PhD	University of Minnesota	Principal Investigator
Joshua E Mervis, BA	University of Minnesota	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Minnesota		Minneapolis	Minnesota	55455	United States

Intervention Browse Module

MeSH Terms

ID	Term
D065908	Transcranial Direct Current Stimulation

Ancestor Terms

ID	Term
D004599	Electric Stimulation Therapy
D013812	Therapeutics
D003295	Convulsive Therapy
D013000	Psychiatric Somatic Therapies

Browse Leaves

Not provided

Browse Branches

Not provided