Brain Stimulation & Generalized Anxiety Study | NCT04751864

Studies
Brain Stimulation & Generalized Anxiety Study

NCT04751864

Sponsor

ProofPilot

Status

Active, not recruiting

Last Update Posted

Feb 12, 2021Actual

Enrollment

150Estimated

Phase

Phase 4

Conditions

Anxiety
Generalized Anxiety Disorder
Generalized Anxiety

Interventions

Cranial Electrotherapy Stimulator (CES) Device

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

Feb 2021

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 15, 2020Actual

Primary Completion Date

Mar 31, 2021Estimated

Completion Date

Jun 21, 2021Estimated

First Submitted Date

Nov 9, 2020

First Submission Date that Met QC Criteria

Feb 9, 2021

First Posted Date

Feb 12, 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

Feb 9, 2021

Last Update Posted Date

Feb 12, 2021Actual

Name	Class
Fisher Wallace	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active Arm	Experimental	Participants receive active device for the full 8 week study	Device: Cranial Electrotherapy Stimulator (CES) Device
Sham Arm	Sham Comparator	Participants receive sham device for the first 4 weeks, and then at the week 5 cross over, receive the active device.	Device: Cranial Electrotherapy Stimulator (CES) Device

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cranial Electrotherapy Stimulator (CES) Device	Device	Fisher Wallace Cranial Electrotherapy Stimulator (CES) Device	Active Arm Sham Arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Beck Anxiety Inventory (BAI) Score	The Beck is a 21 item self-reported scale measuring anxiety	baseline versus week 4

Secondary Outcomes

Measure	Description	Time Frame
Change in Promise Sleep-SD	Change in self reported sleep quality	baseline versus week 4
Change in Patient Health Questionnaire - 8 (PHQ-8)	self reported depression symptoms

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age greater than 21
US resident
Can receive packages to their home via UPS/Fedex/USPS
Licensed Physician Diagnosis of Generalized Anxiety Disorder
Beck Anxiety Inventory Score between 8 and 25
Read/write English
Have not contemplated suicide in the past year
Not been institutionalized for mental health issues.
Not currently experiencing problems with alcohol or drug abuse
Can commit to not drinking alcohol 4 hours before bedtime for the duration of the study
Can commit to two (2) 20 minute sessions per day for 8 weeks
Not under medical supervision for serious medical condition
Not currently being treated for or suspect a mental health issue
Has not used a brain stimulation treatment in one year
No suspected or known history of heart disease
No pacemaker, or any form of medical electronics, including but not limited to a deep - brain stimulator, electronic stent, etc.
Not taking opioids
Are a resident of states in which we have licensed medical professionals
Does not have any co-occurring significant psychiatric disorder that would impair - participant's particationion.
Does not use any illicit drugs
Not participating in any other anxiety study
Not taking medications affecting the nervous system (e.g. psychiatric medications)
Not taking hypnotics or any sleep aid or marijuana (in any form)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
ProofPilot (Remote Virtual Trial)		New York	New York	10003	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D001008	Anxiety Disorders
D000098647	Generalized Anxiety Disorder