AutismPhase 1NMTNCT00503191
NeuroModulation Technique Treatment of Autism
A Phase 1 study testing NeuroModulation Technique in people with Autism and Neurodevelopmental Disorder, run by NeuroModulation Technique Research Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 5 to 10 years
- Conditions the study is for
- Autism, Neurodevelopmental Disorder
- What is being tested?
- NeuroModulation Technique
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Feb 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intention-based Therapy for Autism Spectrum Disorder: Promising Results of a Wait-List Control Study in Children
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.
- Conditions
- Autism, Neurodevelopmental Disorder
- Being tested
- NeuroModulation Technique
- Keywords
- Autism, Neurodevelopmental disorder
- Medical subject headings
- Autistic Disorder, Neurodevelopmental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuroModulation TechniqueBehavioural
Also called NMT
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.
| Study group | Role | What they receive |
|---|---|---|
| Intention-based therapy treatment for autism | Experimental | NeuroModulation Technique Receives: Behavioral: NeuroModulation Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the end of 12 NMT treatment sessions.
Secondary outcomes (1)
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.
Measured: At the end of 12 NMT treatment sessions.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2007 (estimated)
- Study startJul 2007
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AutismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- NeuroModulation Technique Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert H. Weiner, Ph.D., NeuroModulation Technique Research Institute
- Investigators
- Robert H Weiner, Ph.D., Study chair, NeuroModulation Technique Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00503191
- Sponsor's protocol ID
- NMTRI001-01
- Acronym
- NMT
- Status last verified
- Jan 2014
- First submitted
- 16 Jul 2007
- Last updated
- 22 Jan 2014
- Results posted
- No
Publications
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.
PubMed 24439092
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intention-based Therapy for Autism Spectrum Disorder: Promising Results of a Wait-List Control Study in Children
- ClinicalTrials.gov ID
- NCT00503191
- Acronym / sponsor ID
- NMT / NMTRI001-01
- Conditions
- Autism, Neurodevelopmental Disorder
- Keywords
- Autism, Neurodevelopmental disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- NeuroModulation Technique Research InstituteUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 18 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intention-based therapy treatment for autism | Experimental | Behavioral: NeuroModulation TechniqueNeuroModulation Technique |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeuroModulation TechniqueAlso: NMTNeuroModulation 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. | Behavioural | Intention-based therapy treatment for autism |
Primary outcome
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.
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2014.
- Results publication: PubMed 24439092Weiner 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.
- Study results and parent reports may be found here.Link provided by the sponsor.
Related trials for Autism
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Sensory-integration Therapy Verses Augumented Reality-based Training in ASD
Autism Spectrum Disorder
Recruiting
Cumulative and Booster Effects of Multisession Prefrontal tDCS in ASD Adolescents
Transcranial Direct Current Stimulation, Autistic Spectrum Disorder
Not yet recruiting
"Family Resilience And Mind-body Enhancement" (FRAME): A Randomised Controlled Trial
Autism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert H Weiner, Ph.D. study chair
NeuroModulation Technique Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NeuroModulation Technique in people with Autism and Neurodevelopmental Disorder, run by NeuroModulation Technique Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00503191, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2014.