22Q11 Deletion SyndromeNCT05664412
Using Transcranial Alternating Current Stimulation to Improve Executive Function in 22q11.2 Deletion Syndrome
A study testing at-home tACS using Starstim-Home tES in people with 22Q11 Deletion Syndrome and tACS, run by Stephan Eliez at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 25 years
- Conditions the study is for
- 22Q11 Deletion Syndrome, tACS
- What is being tested?
- at-home tACS using Starstim-Home tES
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- 20 Oct 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- Epilepsy
- Deep brain stimulation electrodes
- Traumatic brain injury
- Facial metal implants
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University of Geneva
Geneva, Canton of Geneva, 1200
Stephan Eliez, MD, + 41 22 322 89 35 ext. +41, stephan.eliez@unige.ch
About this study
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
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.
Read the 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.
- Conditions
- 22Q11 Deletion Syndrome, tACS
- Being tested
- at-home tACS using Starstim-Home tES
- Medical subject headings
- 22q11 Deletion Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
at-home tACS using Starstim-Home tESDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| Active group | Active comparator | Participants will receive 20 sessions of In-phase online theta tACS paired with working memory training. Receives: 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. Receives: Device: at-home tACS using Starstim-Home tES |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
We will investigate whether there is a direct positive effect of tACS on verbal working memory using parallel versions of Digit Span (forward, reverse, and sequencing conditions) inspired Weschler's child/adult intelligence scale (Weschler, 2004, 2011). This will be assessed at three visits: baseline (i.e., pre-stimulation), post-stimulation, 1-month follow-up.
Measured: 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)
We will investigate whether there is a direct positive effect of tACS on visual working memory using parallel versions of Forward memory and Reverse memory subtests, inspired from Leiter-3 (Roid, Mille, Pomplun, \& Koch, 2013) and visual n-back task from Testing of Attentional Performance (Zimmermann \& Fimm, 2002), and Spatial Working Memory from CANTAB (Cambridge Cognition, 2019). This will be assessed at three visits: baseline (i.e., pre-stimulation), post-stimulation, 1-month follow-up.
Measured: 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
Using a visual working memory EEG task, we will explore the oscillatory response of the brain related to working memory. For the EEG analyses, we will use a pipeline that has already been applied to previous data and described in detail (Mancini, Rochas, Seeber, Grent-'t-Jong, et al., 2022a; Mancini, Rochas, Seeber, Roehri, et al., 2022b). All participants will do one EEG at each visit (baseline, post-stimulation, 1-month follow-up).
Measured: An average of 3 months (i.e., duration of the study protocol)
Change in psychotic experiences using Ecological Momentary Assessment (EMA)
Participants will complete a EMA protocol for approximately 3 months (one notification per day). The protocol will be implemented on the RealLife Exp app, developed for clinical research purposes. The data is encrypted at rest and its transmission is secured using several different methods. The data will be transferred on the server of the University of Geneva. Participants will complete the EMA questionnaire once they hear a notification. A follow-up call will be scheduled with the participant to ensure compliance. At each beep, psychotic experiences will be assessed using a series of items (e.g. " Seeing or hearing things others don't perceive ") rated on a 7-point Likert scale (1 = " not at all " to 7 = " extremely "). Feller et al. (2021) showed an association between psychotic experiences (measured by EMA) and severity of psychotic symptoms (measured by a gold standard assessment) in 22q11DS. Their study shows feasibility and validity of assessing psychotic experiences with EMA.
Measured: An average of 3 months (i.e., duration of the study protocol)
Change in Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms using EMA
Details about storage and security of EMA data can be found in Secondary Outcome 5. The EMA questionnaire will include other items, regarding ADHD symptoms. At each beep, ADHD symptoms will be assessed using a series of items (e.g. " Being easily distracted ") rated on a 7-point Likert scale (1 = " not at all " to 7 = " extremely ").
Measured: An average of 3 months (i.e., duration of the study protocol)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2022
- Study start20 Oct 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 22Q11 Deletion SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stephan Eliez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Stephan Eliez, University of Geneva, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05664412
- Sponsor's protocol ID
- 2022-D0123
- Status last verified
- Dec 2025
- First submitted
- 6 Dec 2022
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39513044
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05664412
- Acronym / sponsor ID
- 2022-D0123
- Conditions
- 22Q11 Deletion Syndrome, tACS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Stephan EliezUniversity, hospital or other
- Study start
- 20 Oct 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Active group | Active comparator | Device: at-home tACS using Starstim-Home tESParticipants will receive 20 sessions of In-phase online theta tACS paired with working memory training. |
| Control group | Sham comparator | Device: at-home tACS using Starstim-Home tESParticipants 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. |
Who may qualify
- Ages
- 14 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (4 listed)
- Epilepsy
- Deep brain stimulation electrodes
- Traumatic brain injury
- Facial metal implants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| at-home tACS using Starstim-Home tESWe 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). | Device | Active group, Control group |
Primary outcome
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).
5 secondary outcomes
Change in verbal working memory performance using Digit Span subtest (Weschler's child/adult intelligence scale (2004, 2011).
Time frame: 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)
Time frame: 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
Time frame: An average of 3 months (i.e., duration of the study protocol)
Change in psychotic experiences using Ecological Momentary Assessment (EMA)
Time frame: An average of 3 months (i.e., duration of the study protocol)
Change in Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms using EMA
Time frame: An average of 3 months (i.e., duration of the study protocol)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Derived from this study: PubMed 39513044Latreche 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing at-home tACS using Starstim-Home tES in people with 22Q11 Deletion Syndrome and tACS, run by Stephan Eliez at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of adverse events following tACS (safety and tolerability) (time frame: 1 month (i.e., duration of 20 tACS sessions)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05664412, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025; AzTrials last refreshed its copy on 28 Oct 2026.