Using Transcranial Alternating Current Stimulation to Improve Executive Function in 22q11.2 Deletion Syndrome

Официальное название

Using Transcranial Alternating Current Stimulation With Starstim Home Device to Improve Executive Function in Youths With 22q11.2 Deletion Syndrome: A Randomized Double-blind Sham-controlled Study

Обзор

The purpose of this project is to explore the effects of transcranial alternating current stimulation (tACS) in children, adolescents and young adults with a 22q11.2 microdeletion. The main aim of the present research project is to investigate the effects of repeated, individually tuned high-density (HD) tACS on cognition (i.e., WM performance) and related neuroimaging markers in carriers of the 22q11DS. As cognitive deficits, most notably WM impairment, are among the earliest signs of psychotic disorders, interventions during adolescence aimed at reducing cognitive decline in at-risk individuals may prove effective in delaying or even preventing the later emergence of psychotic symptoms.

Подробное описание

22q11.2 is the neurogenetic disorder with the highest genetic risk of schizophrenia and early diagnosis allows subjects to be followed from early childhood. Not only does atypical cognitive development precede the emergence of the first psychotic symptoms, but it predicts their later severity and further cognitive decline. Even in subjects which premorbid cognitive functioning is already low due to neurogenetic syndromes, further decline in cognitive abilities indicates an increased risk for the emergence of psychotic symptoms.

psychotic symptoms. Thus, early intervention targeting cognition could potentially mitigate the burden of the disease. Individuals carrying the 22q11.2 microdeletion have a distinctive cognitive profile characterized by a dissociation between verbal and visual-spatial memory capacities, supporting a specific deficit in the processing of visuo-spatial information. Memory deficits are therefore a specific weakness of this population. For this reason, we designed a non-invasive brain stimulation protocol to improve visual working memory (WM) in adolescents and young adults with 22q11DS using individual parameters to account for age individual parameters to account for participant age and anatomical variability.

Вмешательства

• Устройство at-home tACS using Starstim-Home tES
  We will use transcranial alternating current stimulation (tACS) of the dorsolateral prefrontal cortex and temporal cortex by adopting a high-density (HD) montage with 3 electrodes to target the dorsolateral prefrontal cortex and 3 electrodes to target the temporal cortex. To select individualized parameters for stimulation, we will first acquire and analyse structural MRI (comprising T1 and T2-weighted sequences) and EEG data during a working memory task. We planned one session of HD-tACS per da

Первичные конечные точки

• Prevalence of adverse events following tACS (safety and tolerability) [Срок оценки: 1 month (i.e., duration of 20 tACS sessions)]

Вторичные конечные точки (5)

• Change in verbal working memory performance using Digit Span subtest (Weschler's child/adult intelligence scale (2004, 2011). [Срок оценки: An average of 3 months (i.e., duration of the study protocol)]
• Change in visuospatial working memory performance using Leiter-3 scales (Roid, Mille, Pomplun, & Koch, 2013), Testing of Attentional Performance (Zimmermann & Fimm, 2002), and CANTAB software (Cambridge Cognition, 2019) [Срок оценки: An average of 3 months (i.e., duration of the study protocol)]
• Change in the oscillatory response of the brain related to working memory with EEG using time-frequency + cross-frequency coupling analyses [Срок оценки: An average of 3 months (i.e., duration of the study protocol)]
• Change in psychotic experiences using Ecological Momentary Assessment (EMA) [Срок оценки: An average of 3 months (i.e., duration of the study protocol)]
• Change in Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms using EMA [Срок оценки: An average of 3 months (i.e., duration of the study protocol)]

Критерии участия

Критерии включения

• Confirmed genetic diagnosis of 22q11DS
• Age between 14 and 25 years old
• Willingness to participate
• Informed Consent signed by the subject and/or the caregiver(s)

Критерии исключения

• Epilepsy
• Deep brain stimulation electrodes
• Traumatic brain injury
• Facial metal implants

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Швейцария · 1 центр

• University of Geneva — Geneva

Публикации

• Latreche C, Mancini V, McGinn N, Rochas V, Ferat V, Forrer S, Schneider M, Eliez S. Safety and feasibility of home-based transcranial alternating current stimulation in youths with 22q11.2 deletion syndrome. Front Neurosci. 2024 Oct 24;18:1453839. doi: 10.3389/fnins.2024.1453839. eCollection 2024. PMID 39513044

Идентификаторы

NCT: NCT05664412 · 2022-D0123

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗