Sicherheit und Wirksamkeit von tPBM für epileptiforme Aktivität bei Autismus (tPBM)
Sicherheit und Wirksamkeit der transkraniellen Photobiomodulation (tPBM) für Personen mit Autismus-Spektrum-Störung und epileptiformer Aktivität
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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 2
Kontakte und Standorte
Studienorte
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Arizona
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Phoenix, Arizona, Vereinigte Staaten, 85050
- Rossignol Medical Center
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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:
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Significant self-abusive or violent behavior or evidence of suicidal ideation, plan or behavior
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Severely affected children as defined by CGI-Severity Standard Score = 7 (Extremely Ill)
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Severe prematurity (<34 weeks gestation) as determined by medical history
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Current uncontrolled gastroesophageal reflux disease since GERD can cause movements that appear like seizures
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Genetic syndromes
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Congenital brain malformations
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Any medical condition that the PI determines could jeopardize the safety of the study subject or compromise the integrity of the data.
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Failure to thrive or Body Mass Index < 5%ile or <5%ile for weight (male <11.2kg; female <10.8kg by CDC 2000 growth charts) at the time of the study.
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Concurrent treatment with drug that would significantly interact with treatment.
- • Stimulants
- • Anti-Psychotics
- • Antihistamines
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Excessive Hair that the caregivers are unwilling or unable to shave or braid.
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Inability to tolerate the required dosage of tPBM treatment due to sensory issues.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: 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. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Childhood Autism Rating Scores (CARS)
Zeitfenster: Baseline, Week 5, Week 11 and Week 15 (One Month Follow-Up)
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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)
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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EEG Delta Power
Zeitfenster: Before Treatment and EEG following treatment (within 6 months)
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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)
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Seizure Frequency
Zeitfenster: Baseline, Week 11 and Week 15 (One Month Follow-Up)
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Seizure log will record the seizure severity and frequency |
Baseline, Week 11 and Week 15 (One Month Follow-Up)
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Social Responsiveness Scale (SRS)
Zeitfenster: Baseline, Week 11 and Week 15 (One Month Follow-Up)
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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)
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Clinical Global Impression Scale (CGI) Improvement
Zeitfenster: 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
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NIH Toolbox
Zeitfenster: Baseline, Week 11 and Week 15 (One Month Follow-Up)
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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)
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OACIS Social Interaction
Zeitfenster: 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
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OACIS Aberrant Behaviors
Zeitfenster: 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
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OACIS Repetitive Behaviors
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
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OACIS Hyperactivity
Zeitfenster: 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
Zeitfenster: 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
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OACIS Sensory Sensitivity
Zeitfenster: 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
|
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OACIS Restricted Behavior
Zeitfenster: 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
|
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OACIS Autism Symptoms
Zeitfenster: Week 11
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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
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Richard E Frye, M.D., Ph.D, Rossignol Medical Center, Phoenix AZ
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
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Studienaufzeichnungsdaten
Haupttermine studieren
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Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
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Zuerst eingereicht, das die QC-Kriterien erfüllt hat
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Letztes eingereichtes Update, das die QC-Kriterien erfüllt
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- tPBM Study
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