Pre-FRONTal Brain STability, Key for Action Against Disability in AGing

NCT04115215 | Unknown

• 1 other identifier: FRONT STAGE (PI19/00734)
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Cognitive Impairment; Motoric Cognitive Risk Syndrome

Keywords

Older adults; Cognitive impairment; Motoric Cognitive Risk Syndrome; Physical disfunction; Multi-component physical exercise program; Transcranial electrical stimulation

Outcome Measures

Primary Outcomes (1)

• Changes in hemoglobin oxygenation during functional tasks, as measured using fNIRS+fDCS optical techniques.

  Our primary outcome will be prefrontal hemoglobin oxygenation during a) cognitive tests, such as phonetic verbal fluency and calculations (2-forward and 3-backward counting), b) normal gait, c) dual task (walking while counting). All the measures will be controlled for extra-cerebral and systemic contributions due to variations in heart-rate, oxygen saturation, respiration rate and end-tidal carbondioxide. Various measures such as those derived from accelerometers to account for potential motion artifacts will be also utilized, followed by a multi-subject analysis.

  Baseline (prior to intervention), 3 and 6 months after completion of the intervention.

Secondary Outcomes (7)

• Cognitive executive function tests - Phonetic Verbal Fluency

  Baseline (prior to intervention), 3 and 6 months after completion of the intervention.

• Rey Auditory Verbal Learning Test (RAVLT)

  Baseline (prior to intervention), 3 and 6 months after completion of the intervention.

• Cognitive executive function tests - SDMT

  Baseline (prior to intervention), 3 and 6 months after completion of the intervention.

• Physical function

  Baseline (prior to intervention), 3 and 6 months after completion of the intervention.

• Motor function

  Baseline (prior to intervention), 3 and 6 months after completion of the intervention.

Other Outcomes (12)

• Spatial temporal parameters of gait

  Baseline (prior to intervention), 3 and 6 months after completion of the intervention.

• Total time of daily physical activity

  7 consecutive days (arms 2 & 3) just after the start of the intervention.

• Clinical comorbidity

  Baseline.

Study Arms (3)

Arm 1

EXPERIMENTAL

Physical exercise (PE)

Behavioral: Physical exercise (PE)

Arm 2

EXPERIMENTAL

Transcranial current stimulation (tCS)

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

Control

ACTIVE COMPARATOR

Educational sessions on healthy aging

Other: Control

Interventions

Physical exercise (PE) BEHAVIORAL

This arm includes 10 sessions of multi-component exercise sessions (including aerobic, resistance, flexibility, dual-tasking) of 1 hour/week of functional group exercise, directed to foster empowerment for subsequent continuation of exercise in community-dwelling older adults referred by primary care to a geriatrician and an expert physical therapist. Participants will receive a leaflet with instructions to perform five strength-based exercises and instructors will recommend participants to perform the exercises and walk at least 15 minutes daily.

Arm 1; Arm 2

Transcranial current stimulation (tCS) DEVICE

This arm includes 1 application/week for 10 weeks during PE, through an adapted commercial helmet. Transcranial current stimulation (tCS) is a neural stimulation technique based on electrical stimulation of selected parts of the brain with direct or alternated electrical current (tDCS or tACS) of very low intensity of 1,5 milliamps (mA), using one or more electrodes placed on the skull. tCS is non-invasive (no surgical procedures) and it is painless, as applied in the proposed protocols.

Arm 2

Control OTHER

Participants of similar profile, randomized to the control group, will undergo weekly 30 minutes educational sessions on healthy aging, including relevant aspects of nutrition, self-care, physical activity, plus measurement of blood pressure, heart rate and peripheral oxygen Hb saturation. These participants will be offered to join the PE program after the 6-months follow-up (end of the study).

Control

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• older adults (65 years or older)
• with Motoric Cognitive Risk Syndrome
• 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)
• mobility impairment (measured as slow gait speed\<0.8 m/s)
• without diagnosed clinical neurological or psychiatric diseases
• with a preserved functional status for the activities of daily living
• who can walk without help from third parties

You may not qualify if:

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

Sponsors & Collaborators

• Parc Sanitari Pere Virgili: lead
• Institute for Photonic Sciences - ICFO: collaborator
• Hospital de la Ribera: collaborator
• Fundacio Ictus Malaltia Vascular: collaborator
• Institut Català de la Salut: collaborator
• Vall d'Hebron Research Institute (sponsor): collaborator

Study Sites (5)

The Institute of Photonic Sciences (ICFO)

Castelldefels, Barcelona, 08860, Spain

Location

Hospital Universitario La Ribera

Alzira, Valencia, 46600, Spain

Location

Institut Català de la Salut

Barcelona, 08004, Spain

Location

Parc Sanitari Pere Virgili

Barcelona, 08023, Spain

Location

Fundació Ictus

Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Exercise; Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Marco Inzitari, PhD

  Parc Sanitari Pere Virgili - Vall d'Hebron Institute of Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The investigators performing the follow-up assessments will be blind to randomization. In light of the difficulty to guarantee a complete blinding, these investigators will record if blinding is disclosed by participants during the interview.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2019
• First Posted: October 3, 2019
• Study Start: March 23, 2020
• Primary Completion: March 23, 2023
• Study Completion: March 23, 2023
• Last Updated: July 2, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (5)