Trial Outcomes & Findings for A Trial To Evaluate The Efficacy of Magnetic Resonant Therapy in Autism (NCT NCT01985308)

NCT ID: NCT01985308

Last Updated: 2024-08-07

Results Overview

The Childhood Autism Rating Scale is a behavior rating scale that measures the severity of autism symptoms in children. It consists of 15 sub-domains including relating to people, adaptation to change, verbal communication, and visual response. Each sub-domain is rated between 1-4, with the total score ranging from a low of 15 to a high of 60. Scores below 30 indicate that the individual is in the non-autistic range. Scores between 30 and 36.5 indicate mild to moderate autism, and scores from 37 to 60 indicate severe autism. A higher CARS score represents more severe symptoms. In the present study, the primary outcome was numerical change in CARS score between baseline and Week 5 (end of the double-blind portion of the study). The comparison of the mean and standard deviation between groups is reported. Difference in CARS score between the baseline and week 5 (end of double-blind portion of the study). CARS value at 5 weeks minus CARS value at baseline.

Recruitment status

COMPLETED

Study phase

Target enrollment

28 participants

Primary outcome timeframe

5 Weeks

Results posted on

2024-08-07

Participant Flow

Participant milestones

Participant milestones
Measure	MRT-Active Magnetic Field, modulated as per EEG analysis, is active for 6 seconds every minute for 30 minutes per day, 5 days per week x 5 weeks. MRT-Active	MRT-SHAM Magnetic field is not active, but a sham coil is used, for 6 seconds every minute for 30 minutes per day, 5 days per week x 5 weeks. MRT-SHAM
Overall Study STARTED	14	14
Overall Study COMPLETED	14	14
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Trial To Evaluate The Efficacy of Magnetic Resonant Therapy in Autism

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MRT-Active n=14 Participants Magnetic Field, modulated as per EEG analysis, is active for 6 seconds every minute for 30 minutes per day, 5 days per week x 5 weeks. MRT-Active	MRT-SHAM n=14 Participants Magnetic field is not active, but a sham coil is used, for 6 seconds every minute for 30 minutes per day, 5 days per week x 5 weeks. MRT-SHAM	Total n=28 Participants Total of all reporting groups
Age, Categorical <=18 years	14 Participants n=5 Participants	14 Participants n=7 Participants	28 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	7.26 years STANDARD_DEVIATION 2.53 • n=5 Participants	7.64 years STANDARD_DEVIATION 2.4 • n=7 Participants	7.45 years STANDARD_DEVIATION 2.43 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	13 Participants n=7 Participants	23 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	8 Participants n=5 Participants	11 Participants n=7 Participants	19 Participants n=5 Participants
Race/Ethnicity, Customized Asian/Pacific Islander	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized African-American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 5 Weeks

Population: Children diagnosed with Autism Spectrum Disorder

Outcome measures

Outcome measures
Measure	MRT-Active n=14 Participants Magnetic Field, modulated as per EEG analysis, is active for 6 seconds every minute for 30 minutes per day, 5 days per week x 5 weeks. MRT-Active	MRT-SHAM n=14 Participants Magnetic field is not active, but a sham coil is used, for 6 seconds every minute for 30 minutes per day, 5 days per week x 5 weeks. MRT-SHAM
Childhood Autism Rating Scale 2nd Edition (CARS2)	-7.68 units on a scale Standard Deviation 4.56	-1.61 units on a scale Standard Deviation 2.37

POST_HOC outcome

Timeframe: Baseline until after Week 10

Population: Children diagnosed with Autism Spectrum Disorder

Child Autism Rating Scale 2nd Edition (CARS2) consists of 15 Subdomains to rate a child's behavior, characteristics, and abilities against the expected developmental growth of a typical child. This outcome provides the percent of subjects who improved between baseline and Week 10 following all active treatment.

Outcome measures

Outcome measures
Measure	MRT-Active n=28 Participants Magnetic Field, modulated as per EEG analysis, is active for 6 seconds every minute for 30 minutes per day, 5 days per week x 5 weeks. MRT-Active	MRT-SHAM Magnetic field is not active, but a sham coil is used, for 6 seconds every minute for 30 minutes per day, 5 days per week x 5 weeks. MRT-SHAM
Child Autism Rating Scale Subdomain Item 7 (Visual Response) - Percent of Subjects Who Improved	71.4 percentage who improved	—

POST_HOC outcome

Timeframe: Baseline until after Week 10

Population: Children diagnosed with Autism Spectrum Disorder

Outcome measures

Outcome measures
Measure	MRT-Active n=28 Participants Magnetic Field, modulated as per EEG analysis, is active for 6 seconds every minute for 30 minutes per day, 5 days per week x 5 weeks. MRT-Active	MRT-SHAM Magnetic field is not active, but a sham coil is used, for 6 seconds every minute for 30 minutes per day, 5 days per week x 5 weeks. MRT-SHAM
Child Autism Rating Scale Subdomain Item 11 (Verbal Communication) - Percent of Subjects Who Improved	66.0 Percentage who improved	—

Adverse Events

MRT-Active

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

MRT-SHAM

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	MRT-Active n=14 participants at risk Magnetic Field, modulated as per EEG analysis, is active for 6 seconds every minute for 30 minutes per day, 5 days per week x 5 weeks. MRT-Active	MRT-SHAM n=14 participants at risk Magnetic field is not active, but a sham coil is used, for 6 seconds every minute for 30 minutes per day, 5 days per week x 5 weeks. MRT-SHAM
Gastrointestinal disorders Gastrointestinal upset	21.4% 3/14 • Number of events 14 • Adverse events were collected for 12 weeks.	21.4% 3/14 • Number of events 14 • Adverse events were collected for 12 weeks.

Additional Information

Mazaya Soundra, Clinical Trials Manager

Wave Neuroscience, Inc.

Phone: 9492292869

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place