Non-invasive Stimulation of Brain Networks and Cognition in Alzheimer's Disease and Frontotemporal Dementia (NetCogBs)

IRCCS Centro San Giovanni di Dio Fatebenefratelli

Status: Completed

Conditions: Alzheimer's Disease; Frontotemporal Dementia, Behavioral Variant

Treatments: Device: transcranial direct current stimulation (tDCS)

Study type: Interventional

Funder types: Other

Identifiers

NCT03422250

GR-2011-02349787

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Diagnosis of AD or bvFTD according to current clinical criteria (Albert et al., 2011; Rascovsky et al., 2011)
• Ability to provide written informed consent
• Availability of a collateral source

Exclusion criteria

• Moderate/severe dementia
• Presence of any medical or psychiatric illness that could interfere in completing assessments

Exclusion Criteria for MRI and tDCS:

• metal implants, pace-makers, prosthetic heart valves
• claustrophobia
• history of epilepsy
• pregnancy

Exclusion Criteria for controls:

• Current or past history of clinical, neurological, or psychiatric conditions that could interfere with the assessment (e.g., transient ischemic attack, ictus, head trauma, epilepsy, multiple sclerosis, neuropathy, mood disorders, substance abuse)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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45 participants in 4 patient groups

Arm 1

Experimental group

Description:

Alzheimer's disease (AD): anodal tDCS of the default mode network (DMN)

Treatment:

Device: transcranial direct current stimulation (tDCS)

Arm 2

Experimental group

Description:

Alzheimer's disease (AD): cathodal tDCS of the salience network (SN)

Treatment:

Device: transcranial direct current stimulation (tDCS)

Arm 3

Experimental group

Description:

Behavioral-variant frontotemporal dementia (bvFTD): anodal tDCS of the salience network (SN)

Treatment:

Device: transcranial direct current stimulation (tDCS)

Arm 4

Experimental group

Description:

Behavioral-variant frontotemporal dementia (bvFTD): cathodal tDCS of the default mode network (DMN)

Treatment:

Device: transcranial direct current stimulation (tDCS)