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Säkerhet och effekt av tPBM för epileptiform aktivitet vid autism (tPBM)

20 september 2026 uppdaterad av: Richard Frye

Säkerhet och effekt av transkraniell fotobiomodulering (tPBM) för individer med autismspektrumstörning och epileptiform aktivitet

For this study, the proposed intervention will be noninvasively delivered near infra-red (NIR) light - transcranial Photobiomodulation (tPBM) - to the brains of autistic children with abnormal EEGs with epileptiform discharges or with epilepsy. This will occur, twice a week, for 10 weeks. The NIR light is delivered to specific brain areas by Cognilum, a wearable device developed by Jelikalite. The expected outcome is improved focus, improved eye contact, improved speech, improved behavior, and gains in functional skills. Cognilum may impact the clinical practice of treating autism. At the beginning, at five weeks, and at the end of study, the clinician will complete the CARS-2, SRS, CGI, and a caregiver interview; additionally, questionnaires will be administered to caregivers during one of the 1-hour weekly treatment sessions.

Studieöversikt

Studietyp

Interventionell

Inskrivning (Faktisk)

6

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • Arizona
      • Phoenix, Arizona, Förenta staterna, 85050
        • Rossignol Medical Center

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

4 år till 16 år (Barn)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • Autism Spectrum Disorder (diagnosed as Autistic Disorder on the ADOS-2 or the ADI-R).
  • Between 4 and 12 years of age, at baseline.
  • Autism severity of moderate or higher (≥4) under the 7-item clinical global impression-severity scale. Moderate level of autism severity (4) is defined by the diagnosis of ASD with language impairment.
  • Ability to maintain all ongoing complementary, dietary, traditional, and behavioral treatments constant for the study period.
  • Unchanged complementary, dietary, traditional, and behavioral treatments for two months prior to study entry
  • Ability to tolerate procedures, as determined at the discretion of the investigator.
  • At least one 24hr EEG with data in EDF format that is accessible to investigators.

Exclusion Criteria:

  • Significant self-abusive or violent behavior or evidence of suicidal ideation, plan or behavior

  • Severely affected children as defined by CGI-Severity Standard Score = 7 (Extremely Ill)

  • Severe prematurity (<34 weeks gestation) as determined by medical history

  • Current uncontrolled gastroesophageal reflux disease since GERD can cause movements that appear like seizures

  • Genetic syndromes

  • Congenital brain malformations

  • Any medical condition that the PI determines could jeopardize the safety of the study subject or compromise the integrity of the data.

  • Failure to thrive or Body Mass Index &lt; 5%ile or &lt;5%ile for weight (male &lt;11.2kg; female &lt;10.8kg by CDC 2000 growth charts) at the time of the study.

  • Concurrent treatment with drug that would significantly interact with treatment.

    • • Stimulants
    • • Anti-Psychotics
    • • Antihistamines
  • Excessive Hair that the caregivers are unwilling or unable to shave or braid.

  • Inability to tolerate the required dosage of tPBM treatment due to sensory issues.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Near infra-red (NIR) light - transcranial Photobiomodulation (tPBM) - to the brain of autistic child

This is a prospective, open level study comparing 15 individuals with active seizures and 15 individuals with EEG abnormalities before and after, near infra-red (NIR) light - transcranial Photobiomodulation (tPBM) will be the active arm

The proposed intervention will be noninvasively delivered near infra-red (NIR) light - transcranial Photobiomodulation (tPBM) - to the brains of autistic children. The NIR light is delivered to specific brain areas by Cognilum, a wearable device developed by Jelikalite. The expected outcome is improved focus, improved eye contact, improved speech, improved behavior, and gains in functional skills.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Childhood Autism Rating Scores (CARS)
Tidsram: Baseline, Week 5, Week 11 and Week 15 (One Month Follow-Up)

The CARS is a measure of autism severity completed by a clinician. Lower Score is Better. Scores range from 15 to 60.

Baseline, Week 5, Week 11 and Week 15 (One Month Follow-Up)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
EEG Delta Power
Tidsram: Before Treatment and EEG following treatment (within 6 months)

Delta power is a measures of the amount of brain activity in the delta frequency as measured by overnight EEG

Before Treatment and EEG following treatment (within 6 months)

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Seizure Frequency
Tidsram: Baseline, Week 11 and Week 15 (One Month Follow-Up)

Seizure log will record the seizure severity and frequency

Baseline, Week 11 and Week 15 (One Month Follow-Up)
Social Responsiveness Scale (SRS)
Tidsram: Baseline, Week 11 and Week 15 (One Month Follow-Up)

The SRS is a caregiver report of autism symptoms Lower Score is Better, Scores range from 30 to 90 (T-scores)

Baseline, Week 11 and Week 15 (One Month Follow-Up)
Clinical Global Impression Scale (CGI) Improvement
Tidsram: Week 11

The CGI measures the overall disease change. It is completed by a clinician. Scores range from 1 to 7. Lower score is better. Scores 1 to 3 represent improvement with 1 representing marked improvement, 2 moderate improvement, 3 mild improvement. Score 4 represents no change. Scores 5 to 7 represent worsening with 5 mildly worse, 6 moderately worse and 7 marked worse.

Week 11
NIH Toolbox
Tidsram: Baseline, Week 11 and Week 15 (One Month Follow-Up)

The NIH ToolBox is a set of short assessments for neurodevelopmental assessments. Direction of score depends on individual subtest.

Baseline, Week 11 and Week 15 (One Month Follow-Up)
OACIS Social Interaction
Tidsram: Week 11

CGI Improvement Type Scale Specific for Social Interactions: It is completed by a clinician. Scores range from 1 to 7. Lower score is better. Scores 1 to 3 represent improvement with 1 representing marked improvement, 2 moderate improvement, 3 mild improvement. Score 4 represents no change. Scores 5 to 7 represent worsening with 5 mildly worse, 6 moderately worse and 7 marked worse.

Week 11
OACIS Aberrant Behaviors
Tidsram: Week 11

CGI Improvement Type Scale Specifically for Aberrant Behaviors. It is completed by a clinician. Scores range from 1 to 7. Lower score is better. Scores 1 to 3 represent improvement with 1 representing marked improvement, 2 moderate improvement, 3 mild improvement. Score 4 represents no change. Scores 5 to 7 represent worsening with 5 mildly worse, 6 moderately worse and 7 marked worse.

Week 11
OACIS Repetitive Behaviors
Tidsram: Week 11 Assessment

CGI Improvement Type Scale Specifically for Repetitive Behaviors. It is completed by a clinician. Scores range from 1 to 7. Lower score is better. Scores 1 to 3 represent improvement with 1 representing marked improvement, 2 moderate improvement, 3 mild improvement. Score 4 represents no change. Scores 5 to 7 represent worsening with 5 mildly worse, 6 moderately worse and 7 marked worse.

Week 11 Assessment
OACIS Verbal Communication
Tidsram: Week 11

CGI Improvement Type Scale Specifically for Verbal communication. It is completed by a clinician. Scores range from 1 to 7. Lower score is better. Scores 1 to 3 represent improvement with 1 representing marked improvement, 2 moderate improvement, 3 mild improvement. Score 4 represents no change. Scores 5 to 7 represent worsening with 5 mildly worse, 6 moderately worse and 7 marked worse.

Week 11
OACIS Nonverbal Communication
Tidsram: Week 11

CGI Improvement Type Scale Specifically for Nonverbal communication. It is completed by a clinician. Scores range from 1 to 7. Lower score is better. Scores 1 to 3 represent improvement with 1 representing marked improvement, 2 moderate improvement, 3 mild improvement. Score 4 represents no change. Scores 5 to 7 represent worsening with 5 mildly worse, 6 moderately worse and 7 marked worse.

Week 11
OACIS Hyperactivity
Tidsram: Week 11

CGI Improvement Type Scale Specifically for Hyperactivity. It is completed by a clinician. Scores range from 1 to 7. Lower score is better. Scores 1 to 3 represent improvement with 1 representing marked improvement, 2 moderate improvement, 3 mild improvement. Score 4 represents no change. Scores 5 to 7 represent worsening with 5 mildly worse, 6 moderately worse and 7 marked worse.

Week 11
OACIS Anxiety
Tidsram: Week 11

CGI Improvement Type Scale Specifically for Anxiety. It is completed by a clinician. Scores range from 1 to 7. Lower score is better. Scores 1 to 3 represent improvement with 1 representing marked improvement, 2 moderate improvement, 3 mild improvement. Score 4 represents no change. Scores 5 to 7 represent worsening with 5 mildly worse, 6 moderately worse and 7 marked worse.

Week 11
OACIS Sensory Sensitivity
Tidsram: Week 11

CGI Improvement Type Scale Specifically for Sensory Sensitivity. It is completed by a clinician. Scores range from 1 to 7. Lower score is better. Scores 1 to 3 represent improvement with 1 representing marked improvement, 2 moderate improvement, 3 mild improvement. Score 4 represents no change. Scores 5 to 7 represent worsening with 5 mildly worse, 6 moderately worse and 7 marked worse.

Week 11
OACIS Restricted Behavior
Tidsram: Week 11

CGI Improvement Type Scale. It is completed by a clinician. Scores range from 1 to 7. Lower score is better. Scores 1 to 3 represent improvement with 1 representing marked improvement, 2 moderate improvement, 3 mild improvement. Score 4 represents no change. Scores 5 to 7 represent worsening with 5 mildly worse, 6 moderately worse and 7 marked worse.

Week 11
OACIS Autism Symptoms
Tidsram: Week 11

CGI Improvement Type Scale Specific for Autism symptoms. It is completed by a clinician. Scores range from 1 to 7. Lower score is better. Scores 1 to 3 represent improvement with 1 representing marked improvement, 2 moderate improvement, 3 mild improvement. Score 4 represents no change. Scores 5 to 7 represent worsening with 5 mildly worse, 6 moderately worse and 7 marked worse.

Week 11

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Utredare

  • Huvudutredare: Richard E Frye, M.D., Ph.D, Rossignol Medical Center, Phoenix AZ

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 juli 2024

Primärt slutförande (Faktisk)

10 februari 2026

Avslutad studie (Faktisk)

10 februari 2026

Studieregistreringsdatum

Först inskickad

22 mars 2024

Först inskickad som uppfyllde QC-kriterierna

4 april 2024

Första postat (Faktisk)

8 april 2024

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

22 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

20 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Plan för individuella deltagardata (IPD)

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NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Ja

produkt tillverkad i och exporterad från U.S.A.

Ja

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