Безопасность и эффективность tPBM при эпилептиформной активности при аутизме (tPBM)
Безопасность и эффективность транскраниальной фотобиомодуляции (tPBM) для лиц с расстройствами аутистического спектра и эпилептиформной активностью
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.
Обзор исследования
Статус
Условия
Тип исследования
Регистрация (Действительный)
Фаза
- Фаза 2
Контакты и местонахождение
Места учебы
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Arizona
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Phoenix, Arizona, Соединенные Штаты, 85050
- Rossignol Medical Center
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Н/Д
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: 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. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Childhood Autism Rating Scores (CARS)
Временное ограничение: 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)
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
EEG Delta Power
Временное ограничение: 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)
|
Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Seizure Frequency
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
|
Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Richard E Frye, M.D., Ph.D, Rossignol Medical Center, Phoenix AZ
Публикации и полезные ссылки
Общие публикации
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Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- tPBM Study
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
продукт, произведенный в США и экспортированный из США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .