NeuroModulation Technique Treatment of Autism

Autism Clinical Trial

— NMT  

Official title:

Intention-based Therapy for Autism Spectrum Disorder: Promising Results of a Wait-List Control Study in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00503191
• Other study ID #: NMTRI001-01
• Status: Completed
• Phase: Phase 1
• First received: July 16, 2007
• Last updated: January 19, 2014
• Start date: July 2007
• Est. completion date: February 2009

Study information

• Verified date: January 2014
• Source: NeuroModulation Technique Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether NeuroModulation Technique (NMT) is effective in reducing maladaptive behaviors and increasing adaptive behaviors in children diagnosed with autism.

Hypothesis: Children in the Experimental group will show significant improvement over the Wait-List control group as measured by the Pervasive Developmental Disorder Behavioral Inventory (PDDBI), the Aberrant Behavior Checklist, Community Version (ABC-C), and the Autism Treatment Evaluation Checklist (ATEC). Children in the Wait-List control group will show significant improvement over their baseline measures after receiving NMT treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 10 Years

Eligibility

Inclusion Criteria:

• Qualified participants are those who have received a formal diagnosis of autism from a physician or psychologist using DSM-IV, DSM-IV-TR or ICD-9-CM diagnostic criteria. Parents and/or legal guardian must supply proof of autism diagnosis. Autism (DSM-IV, DSM-IV-R or ICD-9-CM 299.0) must be diagnosed - any other diagnosis such as Pervasive Developmental Disorder (PDD), Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) or Asperger Syndrome is not sufficient for inclusion in this study.

• Children must have had their diagnosis of autism for at least one year prior to the date of the application for participation in this study.

• Children must not have started any new therapies or stopped any ongoing therapies designed to treat their autism such behavior therapy, speech therapy, physical therapy, sensory integration, dietary modification or dietary supplementation, or any alternative or experimental therapies not mentioned here in the 6 months prior to the date of the application for participation in this study.

• During the course of this study, children will be required to continue with any therapies they have been receiving prior to starting the study, and they will be required to not start any new therapies besides NeuroModulation Technique during the course of this study.

• Parents and/or legal guardians of children in the study must be fluent in English and complete all forms and questionnaires in English (for U.S. and Canadian research sites only)

Exclusion Criteria:

• Excluded from participating will be children with any of the following medical conditions: cerebral palsy, Down's syndrome, traumatic brain injury, encephalitis, Lyme disease, cancer, any active infectious disease, endocrine disorder, other mental disorders such as psychotic disorders or other mood disorders including bipolar disorders, or any acute, chronic or unstable medical condition (such as a seizure disorder, Crohn's disease, asthma, bronchitis, etc.) other than autism for which the child has been receiving treatment, medication and/or therapy.

• Also excluded from the study are children who have undergone chelation therapy in the past or are currently undergoing chelation therapy, and children who have displayed significant self-injurious behavior (children who have caused visible harm to themselves).Children with a history of mild to moderate food or airborne allergies, sensitivities, or mild digestive problems are eligible to participate in the study.

• In order to participate in the study, children must not have received any previous NeuroModulation Technique treatment.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autism
• Autistic Disorder
• Mental Disorders Diagnosed in Childhood
• Neurodevelopmental Disorder

Intervention

Behavioral:
• NeuroModulation Technique
NeuroModulation Technique is an informational technique that works by identifying and bringing awareness of the mind-body to incorrect informational states of the nervous system which has led to illness or maladaptive behavior. NeuroModulation Technique then directs the body to correct these information states, thereby helping the nervous system resume more adaptive functioning.

Locations

Country	Name	City	State
United States	Robert H. Weiner, Ph.D.	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
NeuroModulation Technique Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (1)

Weiner RH, Greene RL. Intention-based therapy for autism spectrum disorder: promising results of a wait-list control study in children. Explore (NY). 2014 Jan-Feb;10(1):13-23. doi: 10.1016/j.explore.2013.10.005. Epub 2013 Oct 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary efficacy outcome measures include mean change from start of treatment to end of treatment on the PDDBI Autism Composite Index, the ABC-C Total Score, and the ATEC Total Score.	Children in both the Experimental and Wait-List control groups will show significant improvement over their respective baseline scores in these primary outcome measures following NMT treatment, which will reflect an improvement in adaptive behaviors as well as a decrease in maladaptive behaviors.	At the end of 12 NMT treatment sessions.	No
Secondary	Secondary outcome measures include mean change from start of treatment to end of treatment on the remaining subscales of the PDDBI, the ABC-C, and the ATEC.	Children in both the Experimental and Wait-List control groups will show significant improvement over their respective baseline scores in these secondary outcome measures following NMT treatment, which will reflect an improvement in adaptive behaviors as well as a decrease in maladaptive behaviors.	At the end of 12 NMT treatment sessions.	No

External Links

•   Study results and parent reports may be found here.