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

NCT05664412 | Recruiting

• 1 other identifier: 2022-D0123
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

22Q11 Deletion Syndrome; tACS

Outcome Measures

Primary Outcomes (1)

• Prevalence of adverse events following tACS (safety and tolerability)

  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).

  1 month (i.e., duration of 20 tACS sessions)

Secondary Outcomes (5)

• 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 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 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 psychotic experiences using Ecological Momentary Assessment (EMA)

  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)

Study Arms (2)

Active group

ACTIVE COMPARATOR

Participants will receive 20 sessions of In-phase online theta tACS paired with working memory training.

Device: at-home tACS using Starstim-Home tES

Control group

SHAM COMPARATOR

Participants will receive 20 sessions of sham tACS paired with working memory training. After unblinding (by someone from our lab but external to the study), they will receive 20 sessions of in-phase offline theta tACS.

Device: at-home tACS using Starstim-Home tES

Interventions

at-home tACS using Starstim-Home tES DEVICE

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 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).

Active group; Control group

Eligibility Criteria

• Age: 14 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Stephan Eliez: lead

Study Sites (1)

University of Geneva

Geneva, Canton of Geneva, 1200, Switzerland

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

22q11 Deletion Syndrome

Condition Hierarchy (Ancestors)

Craniofacial Abnormalities; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Lymphatic Abnormalities; Lymphatic Diseases; Hemic and Lymphatic Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Hypoparathyroidism; Parathyroid Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: 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).

Study Record Dates

• First Submitted: December 6, 2022
• First Posted: December 23, 2022
• Study Start: October 20, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 2, 2025

Record last verified: 2025-12

Locations

CH (1)