NCT06826261Active, not recruiting
Digital Twins for Model-driven Non-invasive Electrical Brain Stimulation
Home-based Transcranial Electrical Stimulation (tES) in Alzheimer's Disease
Source: ClinicalTrials.gov · Last updated 13 Feb 2025
Brief summary (registry, in English)
The purpose of this study is to obtain preliminary data in advance of a larger clinical trial designed to test whether repeated, daily sessions of at-home transcranial alternating current stimulation (tACS) can lead to a clinically significant improvement in patients with AD. Given the potentially fragile patient population, the investigators propose a pilot study to test feasibility and safety (primary). In this pilot study 30 mild-to-moderate AD patients will be enrolled. The intervention will consist of daily model-optimized and individualized tES delivered for 8 weeks, 5 days per week (40 sessions). tACS will be applied daily for 1 hour and will be paired with extensive neuroimaging, neurophysiological and neuropsychological evaluation at several time points (pre and post treatment) to better characterize patients and their response to treatment. The physiological target of treatment will be to increase gamma activity in the pre-frontal cortex, as this has been associated with cognitive decline in AD, and prior tES work targeting PFC gamma oscillations has shown promising results. The investigators hypothesize that active tACS treatment will result in a comparatively slower progression of cognitive decline and loss of gamma power as compared to sham treatment. To assess this, in this pilot study, a cross-over design will be used. Treatment will be multisession since prior tES work indicates a cumulative effect of each session with stronger therapeutic effects, in line with the underlying Hebbian mechanisms putatively involved in non-invasive brain stimulation.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 9 Jan 2025
- Start date
- 4 May 2023
- Primary completion date
- 30 Jun 2025
- Lead sponsor
- I.R.C.C.S. Fondazione Santa Lucia
- Diseases
- Alzheimer disease
- NCT number
- NCT06826261
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 4 May 2023 to the primary completion date, 30 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- contraindications to MRI (this includes metal implants in the head, pacemaker, cochlear implants, or any other non-removable items if they are contraindications to MR imaging).
- treatment currently or within 3 months before Baseline with any of the following medications: typical and atypical antipsychotics (i.e., Clozapine, Olanzapine); antiepileptics drugs (i.e., Carbamazepine, Primidone, Pregabalin, Gabapentin).
- previous surgeries opening the skull leaving skull defects capable of allowing the insertion of a cylinder with a radius greater or equal to 5 mm.
Other illness
- significant neurodegenerative disorder of the central nervous system other than AD.
- history of seizures (except febrile seizures in childhood).
- Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition - Text Revision (DSM IV-TR) criteria met for any of the following (within the specified period): Major depressive disorder (current), Schizophrenia (lifetime), Other psychotic disorders, bipolar disorder, or substance (including alcohol) related disorders (within the past 5 years).
- any condition that makes the study subject, in the opinion of the investigator, unsuitable for the study.
Other
- significant intracranial focal or vascular pathology verified by an MRI scan.
- skin lesions on the scalp at the proposed electrode sites.
Who the study is looking for
- aged between 50 and 85.
- Clinical Dementia Rating score (CDR) of 0.5-1.
- Mini-Mental State Examination (MMSE) score of 18-26.
- treated with acetylcholinesterase inhibitor for at least one month.
- evidence of low β-amyloid and/or elevated phosphorylated Tau protein as detected by lumbar puncture for cerebrospinal fluid biomarkers analysis for diagnostic purposes or PET.
- have a Caregiver
- have access to wireless internet (wifi) connection in the location where study treatments will be applied
Age in the registry: 50 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS Santa Lucia Foundation Coordinator of this site? Confirm its status | Rome | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.