Closed-loop rTMS-EEG During Visuomotor Integration.

Официальное название

State-dependent Entrainment of Intrinsic Brain Rhythms to Improve Interregional Functional Coupling.

Обзор

This pilot study aims at establishing personalized state-based rTMS for precision neurorehabilitation, we designed a within-subject cross-over study to test closed-loop repetitive transcranial magnetic stimulation and electroencephalography (rTMS-EEG) comparing the targeting of two key nodes in the frontoparietal network during bimanual visuomotor force tracking in persons with upper extremity sensorimotor impairment affecting eye-hand control.

Подробное описание

There is a need for oscillatory or repetitive neuromodulatory tools and methods that are effective in entraining intrinsic neural rhythms to improve inefficient functional coupling within neural circuits. The goal of the proposed study is to develop a closed-loop application of repetitive transcranial magnetic stimulation (rTMS) and electroencephalography (EEG) suitable for use in multidomain precision neural-circuit based rehabilitation studies that permits the time-locked application of rTMS pulses to the phase of the intrinsic neural oscillation (personalized state-based application) in a defined behavioral context (e.g., goal-directed eye-hand control).

Вмешательства

• Устройство repetitive transcranial magnetic stimulation (rTMS)
  rTMS will be applied time-locked to the intrinsic brain rhythms to individually-defined brain regions

Первичные конечные точки

• Change of whole hand grip force precision [Срок оценки: 90 minutes]
• Change of functional brain connectivity. [Срок оценки: 90 minutes]

Критерии участия

Критерии включения

• adult volunteers (age ≥18 years)
• right-hand dominance (defined with the Edinburg Handedness Scale)
• voluntary whole-hand grip force (Medical Research Council scale for muscle force ≥2)
• capable of repeated grasp and release with 5% of maximum voluntary contraction (standardized with an in-house computer-based assessment involving whole-hand grip force tracking upon visual cues with a digital dynamometer).

Критерии исключения

• presence of any MRI risk factors (such as an electrically, magnetically, mechanically activated metal or nonmetal implant including cardiac pacemaker, intracerebral vascular clips, any other electrically sensitive support system, or claustrophobia)
• presence of any contraindications to repetitive transcranial magnetic stimulation, rTMS (e.g., history of seizures or epileptic activity, currently taking medications that lower seizure thresholds)
• any neurological or psychiatric disorders affecting cognitive function (e.g., established dementia) affecting the ability to understand the purpose of the study and give informed consent or ability to complete cognitive testing
• substance use disorder
• visual impairment that precludes completion of scanner tasks
• uncontrolled hypertension despite treatment
• intake of tricyclic anti-depressants
• musculoskeletal disorders affecting bimanual grasp- and release
• pregnancy (or suspected/possible pregnancy or plan to become pregnant in the short term). If the participant is a woman of childbearing potential, a urine pregnancy test will be performed on a standard basis.
• severe aphasia affecting particularly of receptive nature (NIH Stroke Scale, NIHSS Language subsection ≥2) affecting the ability to understand the purpose of the study and give informed consent
• pregnancy

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

Другое

Центры проведения

США · 1 центр

• Medical University of South Carolina — Charleston

Идентификаторы

NCT: NCT07249801 · Pro00144782 · 1P50HD118628-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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