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

Stephan Eliez

Status: Enrolling

Conditions: tACS; 22Q11 Deletion Syndrome

Treatments: Device: at-home tACS using Starstim-Home tES

Study type: Interventional

Funder types: Other

Identifiers

NCT05664412

2022-D0123

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 14 to 25 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups

Active group

Active Comparator group

Description:

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

Treatment:

Device: at-home tACS using Starstim-Home tES

Control group

Sham Comparator group

Description:

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.

Treatment:

Device: at-home tACS using Starstim-Home tES