NeuroModulation Technique Treatment of Autism (NMT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Robert H. Weiner, Ph.D., NeuroModulation Technique Research Institute
ClinicalTrials.gov Identifier:
NCT00503191
First received: July 16, 2007
Last updated: January 19, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Autism
Neurodevelopmental Disorder
Behavioral: NeuroModulation Technique
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intention-based Therapy for Autism Spectrum Disorder: Promising Results of a Wait-List Control Study in Children

Resource links provided by NLM:


Further study details as provided by NeuroModulation Technique Research Institute:

Primary Outcome Measures:
  • 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. [ Time Frame: At the end of 12 NMT treatment sessions. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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. [ Time Frame: At the end of 12 NMT treatment sessions. ] [ Designated as safety issue: No ]
    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.


Enrollment: 18
Study Start Date: July 2007
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intention-based therapy treatment for autism
NeuroModulation Technique
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.
Other Name: NMT

  Eligibility

Ages Eligible for Study:   5 Years to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00503191

Locations
United States, Texas
Robert H. Weiner, Ph.D.
Dallas, Texas, United States, 75231
Sponsors and Collaborators
NeuroModulation Technique Research Institute
Investigators
Study Chair: Robert H Weiner, Ph.D. NeuroModulation Technique Research Institute
  More Information

Additional Information:
Publications:
Weiner RH, Greene RL. Intention-Based Therapy for Autism Spectrum Disorder: Promising Results of a Wait-List Control Study in Children. EXPLORE:The Journal of Science and Healing. 2014:10(1):13-23.

Responsible Party: Robert H. Weiner, Ph.D., Principal Investigator, NeuroModulation Technique Research Institute
ClinicalTrials.gov Identifier: NCT00503191     History of Changes
Other Study ID Numbers: NMTRI001-01
Study First Received: July 16, 2007
Last Updated: January 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by NeuroModulation Technique Research Institute:
Autism
Neurodevelopmental disorder

Additional relevant MeSH terms:
Autistic Disorder
Disease
Child Development Disorders, Pervasive
Mental Disorders
Mental Disorders Diagnosed in Childhood
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014