Sécurité et efficacité du tPBM pour l'activité épileptiforme dans l'autisme (tPBM)
Sécurité et efficacité de la photobiomodulation transcrânienne (tPBM) pour les personnes atteintes de troubles du spectre autistique et d'activité épileptiforme
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
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Arizona
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Phoenix, Arizona, États-Unis, 85050
- Rossignol Medical Center
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Childhood Autism Rating Scores (CARS)
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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EEG Delta Power
Délai: 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)
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Seizure Frequency
Délai: 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)
Délai: 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
Délai: 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
Délai: 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)
|
|
OACIS Social Interaction
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
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|
OACIS Anxiety
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Richard E Frye, M.D., Ph.D, Rossignol Medical Center, Phoenix AZ
Publications et liens utiles
Publications générales
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Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- tPBM Study
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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