Pre-FRONTal Brain STability, Key for Action Against Disability in AGing (FRONT STAGE)

Parc Sanitari Pere Virgili

Status: Unknown

Conditions: Cognitive Impairment; Motoric Cognitive Risk Syndrome

Treatments: Other: Control; Device: Transcranial current stimulation (tCS); Behavioral: Physical exercise (PE)

Study type: Interventional

Funder types: Other

Identifiers

NCT04115215

FRONT STAGE (PI19/00734)

Details and patient eligibility

About

Cognitive and mobility impairments are critical contributors to dementia and disability in older adults, and can be caused by neurodegenerative and neurovascular changes at the pre-frontal (PF) brain areas. In a previous technological project funded by ISCiii, the investigators adapted a non-invasive, point-of-care optical methods (fNRIS/fDCS technology) to study PF metabolism and blood flow activation during cognitive and motor tasks, in older adults with and without cognitive impairment. These methods are sensitive to change after physical exercise (PE) and after selectively and safely stimulating PF areas with electrical transcranial direct current stimulation (tCS). PE and tCS have shown benefits for cognition and mobility in the elderly, but their prolonged effect on PF hemodynamic activation has not been studied. Understanding the specific action of these interventions on the brain, and their clinical cognitive and motor impact, is key to fine-tune appropriate treatment strategies.

The FRONT STAGE project aims to compare, through a 3 arms single-blind randomized clinical trial, the impact of a 10 weeks, 1 hour/week program of PE (arm 1) Vs PE+tCS (arm 2) and Vs a control group (arm 3, healthy aging sessions and control of cardiovascular risk factors). The PE program is already implemented in primary care, as part of another previous project of the investigators' research group. Outcomes will include the optical measurement of PF metabolism and blood flow and clinical measures of cognitive and physical function. Front STAGE project will recruit 93 older adults with cognitive impairment and slow gait, but without dementia or disability in the activities of daily living (N=31 per arm). They will receive a comprehensive geriatric assessment at baseline, together with the optical, cognitive and physical measures, and will be follow-up at 3 and 6 months. Weekly physical activity through accelerometry will be controlled in analyses.

FRONT STAGE project centered on aging and the prevention of dementia and disability, will provide, translationally, more evidence to support and enlarge the clinical application of these interventions, and will contribute to foster further research in this field.

Enrollment: 93 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. older adults (65 years or older)
2. with Motoric Cognitive Risk Syndrome
3. characterized by impaired cognition (which in our case will be confirmed with a Spanish version of the Montreal cognitive Assessment (MOCA), score between 26 and 21)
4. mobility impairment (measured as slow gait speed<0.8 m/s)
5. without diagnosed clinical neurological or psychiatric diseases
6. with a preserved functional status for the activities of daily living
7. who can walk without help from third parties

Exclusion criteria

1. a diagnosis of dementia
2. advanced/terminal disease (life expectancy<1 year)
3. contraindications to exercise and tCS
4. unwilling to give informed consent

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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93 participants in 3 patient groups

Arm 1

Experimental group

Description:

Physical exercise (PE)

Treatment:

Behavioral: Physical exercise (PE)

Arm 2

Experimental group

Description:

Transcranial current stimulation (tCS)

Treatment:

Behavioral: Physical exercise (PE)

Device: Transcranial current stimulation (tCS)

Control

Active Comparator group

Description:

Educational sessions on healthy aging

Treatment:

Other: Control