HomeInfos for PatientsTPS-Therapy for AUTISM is Evidence Level 1b

TPS-Therapy for AUTISM is Evidence Level 1b

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In fact, there is finally scientifically verifiable evidence that it can improve autism. A 2023 study delivered an EBM Level 1b and a 50% improvement in the CGI total score after 3 months, providing conclusive scientific proof of the “very strong” efficacy of this therapy.

In this study, only a single brain region was treated.

Imagine what could be achieved if several scientifically proven neuromodulation techniques such as tDCS and TPS were combined and applied not just to a single brain region but to all involved networks?

 

Severely autistic child undergoing TPS treatment

This boy has an extreme form of autism: Landau-Kleffner syndrome, and was treated here by Petros Kattou at the SOZO Brain Center in Nicosia.

To see the entire case history of this patient, I’ve created a separate page here.

Autism is improvable with Neuromodulation

 

 

Study Results

Details below

Primary Measure: CARS (Childhood Autism Rating Scale)

Secondary Scores: CGI (Clinical Global Impression), AQ, ASAS, Stroop, TMT, SRS, Digit Span, VFT

Effect on CARS Scores

  • 24% reduction in CARS score in the TPS arm after 2 weeks

CGI score (better represents parental assessment)

  • 53.7% Improvement in the CGI total score after 3 months
  • d = 4.12–4.37 for improvement immediately after therapy (very strong)

 

Treatment results in simple German

After just two weeks of TPS, a significant improvement in symptoms was observed – an average of 25%, as measured by an established autism spectrum disorder (CARS).

Even after three months, the effect was still clearly noticeable.

The specialists even saw a more than 50% improvement in overall condition compared to the starting point (according to the CGI after 3 months).

about the CARS, CGI, ATEC score, and other scores

Here in Austria, the ATEC score is more commonly used. A variety of scores were used in the study, primarily referring to the CARS and CGI.

All of these scores are comparable in their results, as they only attempt to reflect actual reality as accurately as possible and to objectify the size of the treatment effect.

For children who are to be treated by us, we ask parents to collect an ATEC score promptly before therapy and to re-evaluate the score monthly for a full year.

Links to jump straight to the information

ATEC Score

The ATEC (Autism Treatment Evaluation Checklist) is a standardized parent- or caregiver-administered instrument for assessing the severity and progression of autism symptoms, particularly for monitoring progress during or after treatment (e.g., behavioral therapy, diet, neuromodulation, medication).

1. Aim and Application

  • Developed by the Autism Research Institute (ARI) in the USA
  • Non-diagnostic, but intended for the evaluation of therapy effects
  • Particularly useful for studies, therapy courses, and self-observation
  • Can be completed online or on paper
  • External assessment, usually by parents, teachers, or therapists

2. Structure of the ATEC

The questionnaire consists of 77 questions, divided into four subscales:

I. Language / Communication (0–28 points)

  • Language comprehension
  • Spontaneous speech
  • Ability for verbal interaction

II. Social behavior (0–40 points)

  • Eye contact
  • Social reactions
  • Proximity to significant others

III. Sensory processing / Cognitivetion (0–36 points)

  • Hyper- or hyposensitivity
  • Repetitive tendencies
  • Gambling behavior

IV. Health / physical behavior (0–75 points)

  • Sleep, digestion, eating behavior
  • Hyperactivity
  • Seizures, self-harm

3. Evaluation

  • Total score: 0–179
  • The lower the score, the less severe the autistic symptoms.
  • Average:
    • <30 points: very mild manifestation.
    • 30–70 points: moderate.
    • >>70 points: severe manifestation.
  • The scores can be tracked over time to visualize improvements (e.g., after TPS, tDCS, etc.).

4. Online Version
The Autism Research Institute offers a free online ATEC questionnaire (also for follow-up):

https://www.autism.org/atec

After completing the questionnaire, you will receive a numerical score and the subscales, optionally also as a PDF or progress chart.

5. Advantages and Limitations
Advantages:

  • Simple, free, repeatable
  • Objectivable progression
  • Subscales assist with targeted therapy planning

Limitations:

  • Subjective – depends heavily on the perception of parents/carers
  • Not suitable for diagnosis
  • No differentiation between autism subtypes

 

CGI Score

The CGI (Clinical Global Impression Scale) score is also used in autism spectrum disorders (ASD) – particularly in studies on the effectiveness of interventions such as medications, behavioral therapies, or neuromodulation (e.g., TPS, tDCS).

It provides a standardized assessment of the severity, improvement, and effectiveness of a treatment from the clinical perspective.

CGI consists of three subscales:

CGI-S (Severity) – Severity

Assesses the overall clinical impression of the severity of the illness on a scale of 1–7:

  • 1 = normal, not ill
  • 2 = borderline ill
  • 3 = mildly ill
  • 4 = moderately ill
  • 5 = markedly ill
  • 6 = severely ill
  • 7 = among the sickest patients ever

CGI-I (Improvement) – Change

Assesses improvement since the start of treatment (also 1–7):

  • 1 = very much improved
  • 2 = much improved
  • 3 = moderately improved
  • 4 = unchanged
  • 5 = moderately worsened
  • 6 = significantly worsened
  • 7 = very much worsened

CGI-E (Efficacy Index – optional)

A combined efficacy index that takes into account benefits and side effects (e.g., in psychotropic drug studies), but is less commonly used in autism.

 

CGI in Autism

  • Is used in many randomized controlled trials (RCTs) – e.g. B. to assess the effectiveness of risperidone, aripiprazole, tDCS, TPS, oxytocin, etc.
  • CGI-I ≤2 (i.e., strong or very strong improvement) is usually considered a therapeutically relevant improvement.
  • Typical use: Before-after assessment by an experienced clinician, sometimes supplemented by external assessments (e.g., by parents or teachers).

Example CGI evaluation in a TPS study on autism:

  • Baseline CGI-S: 5 (significantly ill)
  • After 4 weeks of TPS: CGI-I = 2 (significantly improved)
  • After 3 months: CGI-S = 3 (mildly ill)

In many TPS or tDCS studies, the CGI-I is used as the primary clinical endpoint, precisely because autism symptoms are very heterogeneous and difficult to objectify.

Where can you access / administer the CGI?

The CGI (Clinical Global Impression Scale) is an assessment questionnaire for clinicians – not a self-test. There is no official online tool, as the scale is intended to be administered by an experienced physician or therapist based on clinical assessment.

NeverthelessThere are simple ways to use or implement it, for example for studies or monitoring the progression of autism:

 

  1. Form as PDF or printable version

The CGI can be easily applied manually – here is a clear template for documentation:

CGI-S (Severity)

How severe is the patient’s current illness compared to other patients with the same diagnosis?

  • 1 = normal, not ill
  • 2 = borderline ill
  • 3 = slightly ill
  • 4 = moderately ill
  • 5 = markedly ill
  • 6 = severely ill
  • 7 = among the most severely ill patients

CGI-I (improvement)

How has the patient changed compared to the baseline situation?

  • 1 = very much improved
  • 2 = much improved
  • 3 = moderately improved
  • 4 = unchanged
  • 5 = moderately worsened
  • 6 = markedly worsened
  • 7 = massively worsened

You can, for example, E.g., fill it out by hand at each consultation, add it to the patient file, or record it systematically (e.g., in a Word document or Excel spreadsheet).

  1. Online versions (not validated)

There are some websites or app templates that visually display CGI, e.g. E.g.:

  • PsychTools.de – sometimes offers CGI scales as PDFs
  • REDCap / LimeSurvey – for research purposes, custom CGI forms can be programmed
  • Mobile apps for study purposes – often in clinical trial settings (e.g., ClinicalTrials.gov)

But: None of these are officially validated or recognized under medical law, and lack clinical assessment by a physician.

 

CARS Score

The CARS (Childhood Autism Rating Scale) is one of the most established clinical instruments for diagnosing and assessing the severity of autism spectrum disorders (ASD) in children. It is observation-based, semi-structured, and widely used internationally – including in German-speaking countries.

  1. Aim and Application
  • Developed in 1980 by Eric Schopler et al. at the TEACCH program (University of North Carolina)
  • Used to differentiate between ASD and other developmental disorders
    Also to assess severity (mild to severe)
  • Age range: usually 2–6 years, but can also be used for older children
  • Administered by a trained professional (psychologist, physician, special education teacher) – no self- or parental assessment
  1. Scale Structure

The classic CARS (15 items) assesses 15 behavioral areas on a scale of 1 to 4 points:

The 15 assessment dimensions:

  1. Relationship Skills
  2. Imitational Behavior
  3. Emotional Response
  4. Physical Use
  5. Object Use
  6. Adaptation to Change
  7. Visual Response
  8. Audible Response
  9. Response to Tactile Stimuli
  10. Anxiety or Phobias
  11. Communication (verbal and nonverbal)
  12. Language Use
  13. Activity Level
  14. Intellectual Response
  15. Overall Impression

Each area is rated on a scale of 1 (unremarkable) to 4 (highly noticeable). Intermediate scores (e.g., 1.5, 2.5) are permitted.

  1. Evaluation
  • Total score: 15 to 60
  • Rating:
    • <30 points = no autism
    • 30–36.5 points = mild to moderate autism
    • ≥37 points = severe autism
  1. Variants
  • CARS-2 (2010) is the revised version with:
    • CARS2-ST (Standard): Classical scale
    • CARS2-HF (High Functioning): for older or language-gifted children
    • CARS2-QPC: Parent/Teacher Pre-Information Questionnaire

This version is particularly helpful for Asperger’s syndrome, high-functioning autism, or late diagnoses.

  1. Advantages
  • Clinically valid, proven for decades
  • Available in many languages
  • High interrater reliability
  • Enables standardized progression comparisons
  1. Limits
  • Only to be used by trained professionals
  • Requires direct observation + prior information
  • Not suitable for laypeople or parents to complete online
  • Low sensitivity in the borderline range (e.g., in high-functioning autism)
  1. Sources and Online Resources

Original / Manual (English):

German version:

Scientific articles:

  • Search portals such as PubMed, Google Scholar, e.g.B. Search:
    “CARS autism diagnostic validity site:ncbi.nlm.nih.gov”

No online implementation possible due to licensing requirements and observation-based nature. (unlike e.g. ATEC)

  1. Comparison to ATEC and CGI
Instrument Applicable by Target Type Course suitable?
CARS Professional Diagnosis & Severity Observation Scale yes
ATEC Parents/Carer Therapy Course Questionnaire yes
CGI Doctor/Therapist Subjective Improvement Global Assessment yes

 

Only the ATEC can be effectively completed by parents. Since we are not an autism specialist practice, we do not have the specialized staff to properly evaluate CGI or CARS and therefore ask parents to complete the MONTHLY ATEC evaluation.

 

 

“Finally out of the ‘trial and error’ therapy-schemes” – says Dr. Retzek

So far, all our therapies have been a 'trial'

yes, that we At least TRYING and TAKING UP ON THE TOPIC sets us apart: Commitment and willingness to continue training to better serve the patient!

But, has it achieved much?

Well, 5-20% at best. Unpredictable, sometimes this gets a little better, then that gets a little better – I don’t want to underestimate my previous work, but I’m almost retired now, and this “trial and error” just annoys me. I simply want RESULTS for my patients! Safe and reproducible! Just accompanying them and smoothing out the rough patches every now and then is simply not enough!

ATEC course necessary for our treatment

We don’t treat the children without this parental cooperation.

Parents must confirm this in writing in advance, as well as their willingness to participate in a prospective observational study in which the changes in the child (using the ATEC test) will be subsequently scientifically evaluated (anonymously).

 

Now details about the TPS Autism Study

This randomized, double-blind, sham-controlled clinical trial corresponds EBM Level 1b, meaning:

This treatment is considered a confirmed recommendation, always acceptable, safe, and effective, based on current studies.

Details about the EBM and Level 1b of this study

Evidence Level represents how well the effectiveness of a treatment has been scientifically verified.

  • Class I: is considered a confirmed recommendation, always acceptable, safe, and effective, based on current studies.

Randomized, double-blind, sham-controlled clinical trial – the highest level of experimental study designs in evidence-based medicine (EBM).

Evidence level according to EBM criteria (e.g., Oxford Centre for Evidence-Based Medicine):

The study corresponds to:

EBM Level 1b

  • Definition: Individual randomized controlled trials (RCTs) with narrow confidence intervals.
  • Characteristics met:
    • Randomization
    • Double-blinding
    • Placebo/sham control
    • Clearly defined endpoints (CARS, CGI, etc.)
    • Statistical significance of the results
    • Prospective design
    • Peer-reviewed in a recognized journal (Brain Communications, Oxford University Press)

Relevance and Limitations:

  • Strengths:
    • Very good study design (RCT, double-blind, placebo-controlled)
    • Meaningful endpoints (CARS, CGI, cognitive tests)
    • Sustainability of effect proven over 3 months
    • Effect sizes (Cohen’s d up to 4.3) clinically highly relevant
  • Limitations:
    • Relatively small sample (n=32)
    • Monocentric (only Hong Kong, Chinese adolescents)
    • No biological markers such as EEG, fMRI, or e.g. B. Cytokine profiles
    • No active comparison group (e.g., behavioral therapy)

Conclusion:

The TPS treatment for autism according to this study currently has an EBM level of 1b.
For systematic inclusion in guidelines, an EBM level 1a (meta-analysis of multiple RCTs) would be necessary. However, as initial evidence, the present study provides very strong evidence for the effectiveness of TPS in adolescents with autism.

Study Content

The study by Cheung et al. (2023) is an EBM Level 1b study (randomized, double-blind, controlled) and convincingly shows that TPS (Transcranial Pulse Stimulation) has a significant effect on the core symptoms of autism in adolescents.

 

TPS Effects on the Brain

Biologically and neurologically, the effect is based on mechanotransduction, i.e., the conversion of pulse wave impulses into biochemical cell responses.

how TPS therapy actually works

I will write detailed articles about this with many study references.

Focused Pulse Wave Therapy (TPS in the brain) is currently a major hotspot in scientific research and is used primarily in cosmetic/anti-aging medicine, as it can reverse aging processes.

  • Skin aging by up to 30 years,
  • Erection problems, …..

through the strong stimulation of the body’s own tissue-based stem cells.

Proven Effective Effects

  • Neuroplasticity through activation of mechanosensitive ion channels
  • Release of NO (nitric oxide) → vasodilation, increased cerebral blood flow
  • Angiogenesis and neurogenesis: 50% increase in capillary density (!!!!)
  • Activation of stem cell markers and BDNF
  • Stimulation of deep brain regions (up to 8 cm depth)

The target region was the social-cognitive Network, often impaired in autism.

 

Strength of Effects

Primary Measure: CARS (Childhood Autism Rating Scale)

Secondary Measures: CGI (Clinical Global Impression), AQ, ASAS, Stroop, TMT, SRS, Digit Span, VFT

Effect on CARS Scores:

  • 24% reduction in CARS score in the TPS arm after 2 weeks
  • Effect Size (Cohen’s d):
    • d = 0.83–0.95 immediately and 1 month after treatment (large)
    • d = 2.31 for CGI improvement after 3 months (large)
    • Effects at 3 months: still significant, but tending to decline

CGI score:

  • 53.7% improvement in the total CGI score after 3 months
  • d = 4.12–4.37 for improvement immediately after therapy (very strong)

Which patient groups benefit most?

  • Adolescents with mild to severe autism, ages 12–17 years
  • Completely restricted to Chinese ethnicity (study population), therefore certain ethnic limitations
  • All patients were stable on medication, which minimizes drug falsification

 

Particularly improved were

  • Social interaction
  • Emotional reactivity
  • Verbal communication
  • Anxiety, adaptation to change
  • Sensory integration (olfactory, tactile reactions) in later follow-up

 

Treatment Frequency and Protocol

  • 6 TPS sessions
  • in 2 weeks (every 2 days)
  • 800 pulses/session
  • Energy: 0.2–0.25 mJ/mm²
  • Frequency: 2.5–4 Hz
  • Total duration per session: approximately 30 minutes

 

At SOZO Braincenter, 2000 pulses are administered per session, treating not just one brain region but four regions.

 

Duration of Effect

  • Significantly improved after 2 weeks
  • Effects last 1–3 months
  • Weakening from month 3, but still better than baseline

Conclusion

This study provides a strong evidence base (EBM Level 1b) that TPS is an effective, safe, and sustainable option for treating the core symptoms of autism, particularly in adolescents. A booster interval after 3 months could be considered, but was not tested in the study.

Treatment Costs

TPS is a very expensive therapy. The SOZO Brain Center set the costs at €1,000 per treatment, and we’re talking about six treatments! As a SOZO Fellow, I have to adhere to these guidelines.

However, I personally grant appropriate discounts if socially justified.

We would greatly support the coverage of costs through donations, funds, etc., with appropriate confirmations for the tax authorities. I plan to establish a suitable organization (e.g., a nonprofit association) to support autistic children, which will then ensure tax deductibility. Anyone who would like to give me advice on this is welcome!

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