Segurança e eficácia do tPBM para atividade epileptiforme no autismo (tPBM)
Segurança e eficácia da fotobiomodulação transcraniana (tPBM) para indivíduos com transtorno do espectro do autismo e atividade epileptiforme
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.
Visão geral do estudo
Status
Condições
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 2
Contactos e Locais
Locais de estudo
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Arizona
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Phoenix, Arizona, Estados Unidos, 85050
- Rossignol Medical Center
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Childhood Autism Rating Scores (CARS)
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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EEG Delta Power
Prazo: 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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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Seizure Frequency
Prazo: 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)
Prazo: 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
Prazo: Week 11
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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
Prazo: 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
Prazo: Week 11
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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
Prazo: Week 11
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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
Prazo: Week 11 Assessment
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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
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OACIS Verbal Communication
Prazo: Week 11
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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
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OACIS Nonverbal Communication
Prazo: Week 11
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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
Prazo: Week 11
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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
Prazo: Week 11
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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
Prazo: Week 11
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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
Prazo: Week 11
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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
Prazo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Richard E Frye, M.D., Ph.D, Rossignol Medical Center, Phoenix AZ
Publicações e links úteis
Publicações Gerais
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- Cassano P, Petrie SR, Mischoulon D, Cusin C, Katnani H, Yeung A, De Taboada L, Archibald A, Bui E, Baer L, Chang T, Chen J, Pedrelli P, Fisher L, Farabaugh A, Hamblin MR, Alpert JE, Fava M, Iosifescu DV. Transcranial Photobiomodulation for the Treatment of Major Depressive Disorder. The ELATED-2 Pilot Trial. Photomed Laser Surg. 2018 Dec;36(12):634-646. doi: 10.1089/pho.2018.4490. Epub 2018 Oct 20.
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- Xuan W, Agrawal T, Huang L, Gupta GK, Hamblin MR. Low-level laser therapy for traumatic brain injury in mice increases brain derived neurotrophic factor (BDNF) and synaptogenesis. J Biophotonics. 2015 Jun;8(6):502-11. doi: 10.1002/jbio.201400069. Epub 2014 Sep 8.
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- undefined
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Datas de registro do estudo
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Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
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Atualizações de registro de estudo
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Palavras-chave
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- tPBM Study
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