CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 45 enrolled
Drug / intervention
transcranial direct current stimulation (tDCS)device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03422250
NCT03422250N/ACompleted

A Non-invasive, Multimodal Approach to Restore Functional Networks and Cognition in Alzheimer's Disease and Frontotemporal Dementia

IRCCS Centro San Giovanni di Dio Fatebenefratelli·interventional·Posted Feb 5, 2018·Updated May 19, 2021

In Brief

A clinical study evaluating transcranial direct current stimulation (tDCS) for Alzheimer's Disease and Frontotemporal Dementia, Behavioral Variant. Completed, enrolled 45 participants across 1 site.

Detailed Summary

This pilot study aims to test clinical and connectivity changes following non-invasive stimulation of disease-specific networks in Alzheimer's disease (AD) and behavioral variant frontotemporal dementia (bvFTD). Brain network stimulation will be carried out with transcranial direct current stimulation (tDCS). Target networks will be the default mode network (DMN) and salience network (SN). Twenty AD and 20 bvFTD patients will be recruited and assessed with a comprehensive clinical, behavioral and cognitive battery, and 3 Tesla MRI scan (including resting-state functional MRI, arterial spin labeling, diffusion tensor imaging, structural MRI) at three time-points: baseline, after tDCS, and after 6 months. Patients will be randomized to 2 arms: anodal stimulation of the disease-specific network (DMN in AD, SN in bvFTD) or cathodal stimulation of the anti-correlated network (SN in AD, DMN in bvFTD). The intervention will consist of 10 tDCS sessions over two weeks. Cerebrospinal fluid (CSF) samples will be collected at baseline for biomarker's assessment; blood samples will be collected at each time-point to assess changes in peripheral inflammatory markers. Blood and CSF collection will be optional. A sample of 20 elderly controls will be included for baseline comparisons.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 5, 2018
Enrollment StartJun 8, 2015
Primary CompletionNov 3, 2018
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 8.4 years ago

Interventions

transcranial direct current stimulation (tDCS)device

10 daily 25-minutes tDCS sessions over two weeks.