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

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

Sponsors

Lead sponsor: IRCCS Centro San Giovanni di Dio Fatebenefratelli

Source IRCCS Centro San Giovanni di Dio Fatebenefratelli
Brief 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 3T MRI scan (including resting-state fMRI, 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. 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.

Overall Status Completed
Start Date June 8, 2015
Completion Date November 3, 2018
Primary Completion Date November 3, 2018
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change from baseline in clinical disease severity Baseline, post tDCS (week 3)
Change from baseline in behavioral symptom severity Baseline, post tDCS (week 3)
Change from baseline in functional connectivity Baseline, post tDCS (week 3)
Change from baseline in perfusion Baseline, post tDCS (week 3)
Secondary Outcome
Measure Time Frame
Change from baseline in cognition: memory Baseline, post tDCS (week 3)
Change from baseline in cognition: language Baseline, post tDCS (week 3)
Change from baseline in cognition: executive function Baseline, post tDCS (week 3)
Change from baseline in cognition: visuospatial function Baseline, post tDCS (week 3)
Change from baseline in cognition: emotion recognition Baseline, post tDCS (week 3)
Change from baseline in structural connectivity Baseline, post tDCS (week 3)
Enrollment 66
Condition
Intervention

Intervention type: Device

Intervention name: transcranial direct current stimulation (tDCS)

Description: 10 daily 25-minutes tDCS sessions over two weeks. AD: Anodal tDCS of the default mode network (inferior parietal cortex). bvFTD: Anodal tDCS of the salience network (prefrontal cortex).

Arm group label: Arm 1

Intervention type: Device

Intervention name: transcranial direct current stimulation (tDCS)

Description: 10 daily 25-minutes tDCS sessions over two weeks. AD: Cathodal tDCS of the salience network (prefrontal cortex). bvFTD: Cathodal tDCS of the default mode network (inferior parietal cortex).

Arm group label: Arm 2

Eligibility

Criteria:

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)

Gender: All

Minimum age: 50 Years

Maximum age: 85 Years

Healthy volunteers: Accepts Healthy Volunteers

Location
facility IRCCS Centro San Giovanni di Dio Fatebenefratelli
Location Countries

Italy

Verification Date

November 2018

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: IRCCS Centro San Giovanni di Dio Fatebenefratelli

Investigator full name: Michela Pievani

Investigator title: Principal Investigator

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Arm 1

Arm group type: Experimental

Description: Anodal tDCS of disconnected networks

Arm group label: Arm 2

Arm group type: Experimental

Description: Cathodal tDCS of hyper-connected networks

Acronym NetCogBs
Patient Data Undecided
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Triple (Participant, Care Provider, Outcomes Assessor)

Source: ClinicalTrials.gov