Applied Clinical Neuroscience and Its Effect on Self-repo... | NCT06358560

Studies
Applied Clinical Neuroscience and Its Effect on Self-reported Stress and Other Physiological Markers

NCT06358560

Sponsor

Dylan Saulsbery

Status

Unknown status

Last Update Posted

Apr 10, 2024Actual

Enrollment

15Estimated

Phase

Not provided

Conditions

Stress

Interventions

Therapeutic exercises

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

Apr 2024

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

Mar 4, 2024Actual

Primary Completion Date

Dec 15, 2024Estimated

Completion Date

Dec 15, 2024Estimated

First Submitted Date

Apr 4, 2024

First Submission Date that Met QC Criteria

Apr 9, 2024

First Posted Date

Apr 10, 2024Actual

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

Apr 9, 2024

Last Update Posted Date

Apr 10, 2024Actual

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

The purpose of this study is to see if an applied clinical neuroscience (ACN) approach to the symptom of 'stress' has a measurable effect on an individual's self-reported stress level. Physiological markers will be measured and analyzed to potentially allow for greater insight and aid in setting up any future research on this topic. This is an independent research study.

Detailed Description

Not provided

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

15Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Therapeutic exercises	Other	Rehabilitation exercises designed to achieve the treatment goal

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
NIH Toolbox® Item Bank v3.0 - Perceived Stress (Ages 18+) - Fixed Form	There are 10 questions that are answered on a scale of 1-5, for a final score ranging from 10-50. The higher the number the worse the outcome.	through study completion, an average of 6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Must be 18 years of age or older.
Must be presenting to the clinic for treatment for 'stress'.

Exclusion Criteria:

Under 18 years of age
No vulnerable populations (physical or mental disability, economically or educationally disadvantaged, pregnancy, minors, persons incarcerated).
No participants that have an additional relationship beyond the doctor/patient relationship that exists by nature of a patient committing to treatment (a family member or clinic employee would be excluded from the study).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

The investigators will recruit the first 5-15 people that present to the clinic on their own for treatment for 'stress'.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dylan Saulsbery, DC	Contact	4129999934		admin@thebrainhealthclinics.com
Tyler Hurst, DC	Contact	6159220977		drhurst@thebrainhealthclinics.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Brain Health Clinics	Recruiting	Nashville	Tennessee	37217	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005081	Exercise Therapy

Ancestor Terms

ID	Term
D012046	Rehabilitation
D000359	Aftercare
D003266	Continuity of Patient Care
D005791	Patient Care

Browse Leaves

Not provided

Browse Branches

Not provided