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The Effects of ProFoveate on Reducing Self-Stimulating Behaviors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02088047
Recruitment Status : Terminated (PI decided to end the study)
First Posted : March 14, 2014
Results First Posted : October 9, 2020
Last Update Posted : October 9, 2020
Sponsor:
Information provided by (Responsible Party):
University of Arkansas

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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorders Normal Hearing Normal Intelligence Exhibit Self- Stimulating or Ritualistic Behaviors Device: ProFoveate Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Effects of ProFoveate on Reducing Self-Stimulating Behaviors in Children Diagnosed With Autism Spectrum Disorders
Actual Study Start Date : August 30, 2014
Actual Primary Completion Date : October 4, 2018
Actual Study Completion Date : October 4, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Profoveate
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.
Device: ProFoveate
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.

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



Primary Outcome Measures :
  1. Numbers of Self-stimulating Behaviors [ Time Frame: Baseline to 4 Weeks ]
    Only 4 participants completed enrollment.Only 3 participants completed study. Study was terminated due to low enrollment.



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Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02088047


Locations
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United States, Arkansas
University of Arkansas at Little Rock Speech and Hearing Clinic
Little Rock, Arkansas, United States, 72204
Sponsors and Collaborators
University of Arkansas
Investigators
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Principal Investigator: Samuel Atcherson University of Arkansas
  Study Documents (Full-Text)

Documents provided by University of Arkansas:
Study Protocol  [PDF] September 8, 2014
No Statistical Analysis Plan (SAP) exists for this study.

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Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT02088047    
Other Study ID Numbers: 202241
First Posted: March 14, 2014    Key Record Dates
Results First Posted: October 9, 2020
Last Update Posted: October 9, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by University of Arkansas:
Autism
Self-Stimulating behaviors
Autism Spectrum Disorders
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders