Clinical trial NCT05664412: Using Transcranial Alternating Current Stimulation to Improve Executive Function in 22q11.2 Deletion Syndrome
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: 22Q11 Deletion Syndrome
tACS
Lead sponsor: University of Geneva, Switzerland
Sponsor class: OTHER
First posted: 2022-12-23
Enrollment: 40
Sex: ALL
Minimum age (years): 14
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized double-blind sham-controlled study. 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. The first arm will receive one session of HD-tACS per day for 5 consecutive days every week over four weeks; each session will last 21 minutes. All sessions will occur during cognitive training (i.e., execution of a working memory task). The second arm will first receive 20 sessions of sham stimulation coupled with cognitive training. After the one-month follow-up, they will receive in-phase offline theta tACS (i.e., tACS at rest, with no task).
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

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

Primary outcomes:
measure: Prevalence of adverse events following tACS (safety and tolerability)
timeFrame: 1 month (i.e., duration of 20 tACS sessions)
Secondary outcomes:
measure: Change in verbal working memory performance using Digit Span subtest (Weschler's child/adult intelligence scale (2004, 2011).
timeFrame: An average of 3 months (i.e., duration of the study protocol)
measure: 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)
timeFrame: An average of 3 months (i.e., duration of the study protocol)
measure: Change in the oscillatory response of the brain related to working memory with EEG using time-frequency + cross-frequency coupling analyses
timeFrame: An average of 3 months (i.e., duration of the study protocol)
measure: Change in psychotic experiences using Ecological Momentary Assessment (EMA)
timeFrame: An average of 3 months (i.e., duration of the study protocol)
measure: Change in Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms using EMA
timeFrame: An average of 3 months (i.e., duration of the study protocol)
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: University of Geneva
Study officials:
References: