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The Effects of ProFoveate on Reducing Self-Stimulating Behaviors

Primary Purpose

Autism Spectrum Disorders, Normal Hearing, Normal Intelligence

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

ProFoveate

About this trial

This is an interventional supportive care trial for Autism Spectrum Disorders focused on measuring Autism, Self-Stimulating behaviors, Autism Spectrum Disorders

Eligibility Criteria

10 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Have a documented diagnosis of high functioning autism spectrum disorders (autism, Asperger's syndrome, or Pervasive Development Disorder (PDD) as reported by specialists who use the established criteria (American Psychiatric Association,2000)
Pass a hearing screening at 25 decibels for the frequencies 1000, 2000 and 4000 hertz
Score 85 or above on the Test of Nonverbal Intelligence- 4 (TONI-4; Brown, Sherbenou & Johnsen, 2009)
Exhibit noticeable self- stimulating or ritualistic behaviors (i.e., scratching, hand flapping, eye blinks, etc.) and/or visual characteristics of Autism Spectrum Disorder (ASD) (sensitivity to light, visual fixations, poor eye contact, etc.) as reported by parents and/or observed on videos taken during assessment.

Exclusion Criteria:

Known history of latex allergy
Intelligence Score below 85
Fail the hearing screening

Sites / Locations

University of Arkansas at Little Rock Speech and Hearing Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Profoveate

NonProFoveate

Arm Description

The experimental group will receive the ProFoveate™ intervention along with pre (baseline) and post (end line)intervention assessment. Steel pellets (1.2 mm) will be placed strategically on ears following instructions on how to use the ProFoveate™ pellets. Parents will be provided with a Patient Diary Sheet and will be instructed to perform and document daily checks for placement of the pellets. Parents will be given a one month supply of stainless steel pellets at the initial study visit. Child participants will wear the stainless steel ProFoveate™ pellets for four weeks.

Participants in the control group will have no intervention. They will receive the initial pre testing (baseline) followed by post testing after 4 weeks.

Outcomes

Primary Outcome Measures

Numbers of Self-stimulating Behaviors

Only 4 participants completed enrollment.Only 3 participants completed study. Study was terminated due to low enrollment.

Secondary Outcome Measures

Full Information

NCT ID

NCT02088047

First Posted

March 10, 2014

Last Updated

September 14, 2020

Sponsor

University of Arkansas

1. Study Identification

Unique Protocol Identification Number

NCT02088047

Brief Title

The Effects of ProFoveate on Reducing Self-Stimulating Behaviors

Official Title

The Effects of ProFoveate on Reducing Self-Stimulating Behaviors in Children Diagnosed With Autism Spectrum Disorders

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Terminated

Why Stopped

PI decided to end the study

Study Start Date

August 30, 2014 (Actual)

Primary Completion Date

October 4, 2018 (Actual)

Study Completion Date

October 4, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Arkansas

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This study is designed to pilot an intervention technique to reduce the self-stimulating behaviors seen in individuals with autism spectrum disorders using intervention with ProFoveate pellets. Self-stimulating behaviors like hand flapping, eye blinking, and rocking, can interfere with the individual's ability to interact with their peers. Participants will wear the pellets for four week and measures with taken again. Another group of participants will not get the pellets. Both groups will be tested at the beginning and end of the study. Any variations in self-stimulating behaviors will be documented through parent report, Observational data. The investigators hypothesize that they will see changes in self- stimulating behaviors as a result of the strategic placement of the ProFoveate™ pellets on the ears of one group of the participants.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Autism Spectrum Disorders, Normal Hearing, Normal Intelligence, Exhibit Self- Stimulating or Ritualistic Behaviors

Keywords

Autism, Self-Stimulating behaviors, Autism Spectrum Disorders

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Profoveate

Arm Type

Experimental

Arm Description

Arm Title

NonProFoveate

Arm Type

No Intervention

Arm Description

Participants in the control group will have no intervention. They will receive the initial pre testing (baseline) followed by post testing after 4 weeks.

Intervention Type

Device

Intervention Name(s)

ProFoveate

Intervention Description

ProFoveate™ intervention for nystagmus is a management approach comprised of non-magnetic, 1.2 mm spheres that can be made from either stainless steel, gold plated stainless steel or titanium, placed strategically about the face and ears and a set of exercises designed to support improved vision for patients with nystagmus.The spheres (i.e., stimulating press balls or pellets) are supplied in packages of 20 with each sphere supplied on a transparent hypoallergenic adhesive tape approximately 7.6 mm in diameter. Within each package, all spheres are individually contained on a single paper backing measuring approximately 8.5 cm by 1.7 cm. Individual pellets (with adhesive tape) are removed from the backing as needed according to the prescribed treatment regimen.

Primary Outcome Measure Information:

Title

Numbers of Self-stimulating Behaviors

Description

Only 4 participants completed enrollment.Only 3 participants completed study. Study was terminated due to low enrollment.

Time Frame

Baseline to 4 Weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Have a documented diagnosis of high functioning autism spectrum disorders (autism, Asperger's syndrome, or Pervasive Development Disorder (PDD) as reported by specialists who use the established criteria (American Psychiatric Association,2000) Pass a hearing screening at 25 decibels for the frequencies 1000, 2000 and 4000 hertz Score 85 or above on the Test of Nonverbal Intelligence- 4 (TONI-4; Brown, Sherbenou & Johnsen, 2009) Exhibit noticeable self- stimulating or ritualistic behaviors (i.e., scratching, hand flapping, eye blinks, etc.) and/or visual characteristics of Autism Spectrum Disorder (ASD) (sensitivity to light, visual fixations, poor eye contact, etc.) as reported by parents and/or observed on videos taken during assessment. Exclusion Criteria: Known history of latex allergy Intelligence Score below 85 Fail the hearing screening

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Samuel Atcherson

Organizational Affiliation

University of Arkansas

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Arkansas at Little Rock Speech and Hearing Clinic

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72204

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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The Effects of ProFoveate on Reducing Self-Stimulating Behaviors

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