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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Prevalence of adverse events following tACS (safety and tolerability)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Care providers, outcome assessors, data analysts, and a research assistant who will follow the procedures remotely will be blind. A person in the lab not directly involved in any of the previously mentioned activities will be aware of the randomization for safety reasons.
Eligibility Criteria
- Ages
- 14 Years to 25 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Deep brain stimulation electrodes
- •Traumatic brain injury
- •Facial metal implants
Outcomes
Primary Outcomes
Prevalence of adverse events following tACS (safety and tolerability)
Time Frame: 1 month (i.e., duration of 20 tACS sessions)
Safety and tolerability of using at-home stimulation in a group of youths with neurodevelopmental disorders (i.e., 22q11DS) with the help of caregivers. It will be measured using a homemade questionnaire assessing the presence and intensity of side effects of tACS (e.g., headache, tingling, skin redness, neck pain). Each side effect will be rated on a intensity scale from 1 (absent) to 4 (severe). In addition, we will assess whether the side effect is associated with tACS, from 1 (no association) to 5 (certain association). This questionnaire is present in the Clinical Report Form (CRF) and will be filled after each stimulation session (both tACS and sham stimulation).
Secondary Outcomes
- Change in verbal working memory performance using Digit Span subtest (Weschler's child/adult intelligence scale (2004, 2011).(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(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)(An average of 3 months (i.e., duration of the study protocol))
- Change in Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms using EMA(An average of 3 months (i.e., duration of the study protocol))
- Change in psychotic experiences using Ecological Momentary Assessment (EMA)(An average of 3 months (i.e., duration of the study protocol))
Investigators
Stephan Eliez
Professor
University of Geneva, Switzerland