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Идёт набор NCT06345963

Enhancing Brain Connectivity in Schizophrenia Through Neuromodulation (Study 1)

Без фазы С лечением Schizophrenia

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: active H-coil delivered rTMS.
Кому может быть актуально
Состояния в реестре: Schizophrenia. Базовые параметры: 18 лет — 60 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

Patients with schizophrenia spectrum disorder (SSD) will be exposed to active repetitive transcranial magnetic stimulation (rTMS) from H coil for improving white matter integrity.

Подробное описание

Schizophrenia is a severe mental illness that affects about 1% of the population but a major source of disability. Information processing between brain regions occurs due to transfer of electrical impulses among them. This process is determined by the existing neuronal/fiber connections, which may be altered and or modified in the presence of neuronal stimulation or cognitive intervention. The frontal lobe information flow is critical for higher cognitive functions, thought processes, and proper emotional and behavioral responses. Improving the myelination in the frontal lobe may increase cognitive functions and reduce risks to develop symptoms of schizophrenia. The investigators propose that increasing electrical signaling in the frontal white matter in patients with schizophrenia may also enhance myelination and improve the white matter integrity.

The patients with schizophrenia will receive active repetitive transcranial magnetic stimulation (rTMS) treatment. The rTMS with H coil is FDA-cleared for short-term smoking cessation in the general population. Its efficacy in myelination modulation has not been evaluated.

Вмешательства

  • Устройство active H-coil delivered rTMS
    Multiple trains of rTMS in a day, for multiple days.

Первичные конечные точки

  • Brain microstructural integrity as indicated by white matter fractional anisotropy (FA) values as assessed by magnetic resonance imaging (MRI) [Срок оценки: baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline)]
  • Brain connectivity as indicated by resting-state functional connectivity (rsFC) values as assessed by functional MRI (fMRI) [Срок оценки: baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline)]
Вторичные конечные точки (12)
  • Electrophysiological response as indicated by mismatch negativity as assessed by electroencephalography (EEG) [Срок оценки: baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline)]
  • Electrophysiological response as indicated by steady-state auditory evoked responses from electroencephalography recording (EEG) [Срок оценки: baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline)]
  • Cognitive insight as assessed by the Beck Cognitive Insight Scale [Срок оценки: baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline)]
  • Depression as assessed by the Depression State and Trait Scale (DST) - state [Срок оценки: baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline)]
  • Depression as assessed by the Depression State and Trait Scale (DST) - trait [Срок оценки: baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline)]
  • Depression as assessed by the Calgary Depression Scale [Срок оценки: baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline)]
  • Depression as assessed by the Beck Depression Inventory [Срок оценки: baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline)]
  • Perception as assessed by the Perception State and Trait Scale - state [Срок оценки: baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline)]
  • Perception as assessed by the Perception State and Trait Scale - trait [Срок оценки: baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline)]
  • Delusion as assessed by the 21-item Peters Delusion Inventory (PDI-21) [Срок оценки: baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline)]
  • Emotion regulation as assessed by the Profile of Mood States (POMS) [Срок оценки: day 1 after baseline, day 2 after baseline, day 3 after baseline, day 4 after baseline, day 5 after baseline, day 9 after baseline, day 10 after baseline]
  • Hallucination as assessed by the Revised Hallucinations Scale (RHS) [Срок оценки: day 1 after baseline, day 2 after baseline, day 3 after baseline, day 4 after baseline, day 5 after baseline, day 9 after baseline, day 10 after baseline]

Критерии участия

Критерии включения

  • Male and female ages between ages 18-60 years
  • Ability to give written informed consent (age 18 or above)
  • Diagnosed with schizophrenia-spectrum disorder and Evaluation to Sign Consent (ESC) above 10.

Критерии исключения

  • Inability to sign informed consent.
  • Any history of seizures.
  • Any acute and unstable major medical illnesses that may affect normal brain functioning. Examples of these conditions include, but not limited to, recent stroke, seizure, history of significant head trauma, CNS infection or tumor, other significant brain neurological conditions (As this is a study of medical comorbidity, most medical conditions, once stable, are not exclusion criteria).
  • Taking > 400 mg clozapine/day.
  • Failed TMS screening questionnaire.
  • Significant alcohol or other drug use (substance dependence within 6 months or substance abuse within 1 month) other than nicotine or marijuana dependence.
  • A history of thrombosis, family history of thrombosis, or medical conditions that may lead to a hypercoagulable state (increased chance to develop blood clots)
  • Woman who is pregnant (child-bearing potential but not on contraceptive and missing menstrual period; or by self-report; or by positive urine pregnancy test).
  • History of head injury with loss of consciousness over 10 minutes; history of brain surgery
  • Cannot refrain from using alcohol and/or marijuana 24 hours or more prior to experiments.
  • Students and employees currently involved with our lab (lab employees and personnel will be excluded from the study to avoid possible coercion or possible appearance of coercion, or chance of breach of privacy and confidentiality).
  • For MRI, unable to undergo MRI scanning due to metallic devices or objects (cardiac pacemaker or neurostimulator, some artificial joints, metal pins, surgical clips, or other implanted metal parts) or claustrophobic to the scanner.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • The University of Texas Health Science Center, Houston — Houston

Идентификаторы

NCT: NCT06345963 · HSC-MS-23-1044 (study 1)

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗