"As the treatment continued his rages subsided and by about the sixth month, had ceased altogether."
"His ATEC score dropped from 113 to 60 and he began exhibiting an urge to speak."

"The sheer scale and apparent permanence of the improvements that occurred in our subjects, i.e., up to 94% reduction in ATEC scores..."

NEMO Therapeutics-B1_edited_edited_edited_edited.jpg
Study Approach

Our pilot studies with NEMO Therapy commenced in 2010.  Only children between the ages of 6-18 with a diagnosis of autism spectrum disorder by a medical professional were accepted. Our first five subjects were pre-teens and teenagers [1]. The only children excluded were those on pharmaceuticals such as aripiprazole or risperidone. This was done to avoid any potential adverse reaction to hyperoxia and the possibility of the drug influencing any response. Once a child was accepted for entry into a pilot study, we required their caregivers to provide serial ATEC reports for a period of 6 to 8 weeks prior to starting therapy. This enabled us to build a database of ATEC scores to establish the subject’s severity and stability and enabled us to see how much the child’s behaviours varied naturally prior to treatment. Using this data, we were able to establish the starting ATEC score and a standard deviation for each subject. A standard deviation is a numerical value that, in this case, indicates the degree of natural variation in an individual’s behaviour as measured by the pre-treatment ATEC scores, and was used in assessing the response (i.e., degree of change) to treatment. With respect to what the change in score means in this calculation, Michael Aman Ph.D., the developer of the ABC chart, advised that in autism a reduction of one standard deviation is considered a clear clinical improvement [3].  Another important meter of success in clinical trials is Patient-Reported Outcome (PRO) which provides insight into changes occurring in the subject’s quality of life and, in this case, the family’s as well. We recognised none of our subjects would be able to report on their status so, in addition to the ATEC’s every two to three weeks, caregivers (in every case the child’s mother) were asked to provide a short subjective review, perhaps a paragraph or two, describing the child’s status over each reporting period. These subjective reviews were provided voluntarily and in practice often ran on to several pages. They gave us a unique subjective and often highly emotional insight into the changes as they happened in the child from the caregiver’s perspective and how this was impacting the family dynamic.

We have now conducted 10 separate pilot studies since 2010, with study durations varying between 3 and 18 months. All subjects responded readily to the treatment. For our first five studies treatments were administered 5 days per week. Based on the response in those studies we came to believe 3 treatments is more effective and introduced this reduced requirement in our later studies. All studies were conducted in the subjects’ homes using an early delivery system with treatments administered by the child’s mother on a schedule that fit with the family’s daily activities. The starting data points and those generated during the ongoing assessments are clearly shown in the charts we maintained for each subject. All our subjects were geographically separated and unaware of each other [1].

Subjects 1 & 2
Subject1.png

Figure 1: Subject 1 Total ATEC scores before and during a 1½-year course of treatment and during the ten-year follow-up. The final datapoint is the ATEC assessment conducted by the mother 14th May 2022. 

Subject 1, the younger of the two, was 12 and a half years old when he started in the study (Figure 1). At start of treatment, he had a mean baseline ATEC score of 101, just three points below the ATEC score of 104 for severe autism. His standard deviation was 9.43.  When treatment was stopped by his mother at about 18 months his ATEC score was 9 meaning that he had improved by almost 10 (9.76) standard deviations over the course of treatment. His total ATEC scores fluctuated slightly in the lower part of the mildly autistic (0-30) range over the ten-year follow-up, and just happened to be 18 on the day the ten-year ATEC was assessed by his mother. Subject 2 was the older child and suffered from uncontrollable rages, during which he would attack anybody close to him. He was a few weeks away from his 14th birthday when he started NEMO Therapy and had an average baseline ATEC score of 82 (Figure 2). His pre-treatment standard deviation was 6.55.  When treatment was stopped by his mother at about 18 months his ATEC score was 5 meaning he had improved by almost 12 (11.76) standard deviations. Like his brother, he oscillated in the lower portion of the mildly autistic range throughout the ten-year follow-up and just happened to be 4 on the day the ATEC was assessed by his mother. There are several points of note about this subject. As the treatment continued his rages subsided and by about the sixth month, had ceased altogether.  He also began to mature and started showing an interest in things more in line with his chronological age and, of his own volition, threw out all his age-inappropriate toys. Both brothers stopped treatment at the same time. Over the ten-year follow-up, they have shown no significant regression despite several disruptive events of the type that would normally cause an autistic child to have a meltdown. These include the loss of a beloved family pet, moving to a new house, and for the younger brother entering puberty. These boys are now young men in their 20’s and play an active role in the day-to-day running of a small farm owned by the family (Figure 3) [1].

Subject2.png

Figure 2:  Total ATEC scores before and during a 1½-year course of treatment and during the ten-year follow-up. The final datapoint is the ATEC assessment conducted by the mother 14th May 2022. 

Figure 3:  Subject 2 getting ready to plough a field at age 19

The magnitude of the changes seen in our subjects during these uncontrolled pilot studies, while subject to verification by controlled research, seem to support the veracity of our belief that NEMO Therapy stimulates angiogenesis and physiological remodelling in the autism brain [2]. Further, this seems to be confirmed by long-term follow-up, which shows no regression of symptoms. For example, including the most recent ATEC evaluation completed on 14th May 2022, we have now followed our first two subjects, who are brothers, for more than ten years (Figures 1 & 2).

Subject 4
Subject4.png

Figure 4: ATEC results for Subject 4 during baseline, treatment, and follow-up periods. A – Total score. Treatment was terminated at the time of the move at approximately 350 days.

Our Results and Outcomes

Another example is Subject 4 whose starting baseline score was 113 (Figure 4) and his pre-treatment standard deviation was 3.31.  He was 12 years old at start of therapy, a severely autistic and disabled child. He could sign about ten requests and had a very small vocabulary of basic words which he used in a slurred, quiet voice. He would shake his head, yes or no, in response to questions.  He would ask for something by looking at the thing he wanted, raising his eyebrows to request it, and then at his mother for her response. His mother’s subjective comments were prolific and often very emotional. When Subject 4 exhibited a new or significant change in behavior, his mother would refer to them as “firsts.” She reported many firsts following commencement of NEMO Therapy, such as when Subject 4 gave her a spontaneous kiss which he had never done before; that in one week, he had cooperated completely in getting a haircut, a medical examination, and a dental checkup including getting his teeth cleaned. She also noted that regarding the dental appointment, this was the first time he had not needed to be sedated or restrained by several adults for the dentist to complete his work. Subject 4’s response over the course of the 350 days he received NEMOTherapy was remarkable. His ATEC score dropped from 113 to 60 and he began exhibiting an urge to speak. Unfortunately, the program was stopped at 350 days because the family had to move and could not continue with the study. The cessation of therapy is marked “Move” on Figure 4. Subject 4 maintained this final score without regression during the follow-up period even though the family moved several times before settling and he was entering puberty. His lowest total score was 58, an improvement of almost 17 (16.62) standard deviations and was reported about 1½ years into the follow-up period (Figure 4). We eventually lost touch with the family and were unable to maintain follow-up longer than two years. Of her own volition, Subject 4’s mother made a video during the pilot study and sent it to us. It was recorded in their home by her husband using his cell phone. In it she described her own experience and how the changes she saw affected her son and her family. We made some minor edits for continuity and gave it a title “A Caregivers story.” It is about nine minutes long and available to view here!

Subject2Tractor_edited.jpg
References

1.     Peterson RE, Allen MW. Evolution and Preliminary Testing of a Hyperoxic Therapy for Autism Spectrum Disorders. Autism  Open Access 2018;8:4 doi: 10.4172/2165-7890.1000233

2.   Peterson RE, Allen MW. Hypothesis for How Hyperoxic Therapy May Facilitate Effective Biologic “Correction” of Autism Spectrum Disorders. Autism Open Access 2020;10:250. doi:10.35248/2165-7890.20.10.250

3. Peterson RE.  Personal communication with MG Aman, Ph.D. October 2016.