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Cognitive ImpairmentFRONT STAGENCT04115215

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

A study testing Physical exercise (PE) and Transcranial current stimulation (tCS) in people with Cognitive Impairment and Motoric Cognitive Risk Syndrome, run by Parc Sanitari Pere Virgili at 5 sites in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and older
What is being tested?
Physical exercise (PE) and Transcranial current stimulation (tCS)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
93 participants
Where
5 sitesSpain
Study dates
23 Mar 2020to 23 Mar 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Spain5 sites

  • Hospital Universitario La Ribera

    Alzira, Valencia, 46600

  • Institut Català de la Salut

    Barcelona, 08004

  • Parc Sanitari Pere Virgili

    Barcelona, 08023

  • Fundació Ictus

    Barcelona, 08036

  • The Institute of Photonic Sciences (ICFO)

    Castelldefels, Barcelona, 08860

Other trials in Spain

About this study

Official title: Pre-FRONTal Brain STability, Key for Action Against Disability in AGing: The FRONT STAGE Project

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.

Being tested
Physical exercise (PE), Transcranial current stimulation (tCS), Control
Keywords
Older adults, Cognitive impairment, Motoric Cognitive Risk Syndrome, Physical disfunction, Multi-component physical exercise program, Transcranial electrical stimulation
Medical subject headings
Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physical exercise (PE)Behavioural

    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.

  • 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.

  • ControlOther

    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).

Study groups in NCT04115215
Study groupRoleWhat they receive
Arm 1ExperimentalPhysical exercise (PE)
Receives: Behavioral: Physical exercise (PE)
Arm 2ExperimentalTranscranial current stimulation (tCS)
Receives: Behavioral: Physical exercise (PE); Device: Transcranial current stimulation (tCS)
ControlActive comparatorEducational sessions on healthy aging
Receives: Other: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (7)

  1. Cognitive executive function tests - Phonetic Verbal Fluency

    Phonetic verbal fluency will be measured by scoring total number of words (not repeated) per unit of time, with higher rates revealing better performance.

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

  2. Rey Auditory Verbal Learning Test (RAVLT)

    Rey Auditory Verbal Learning Test (RAVLT) is a validated neuropsychological test used to assess verbal memory function.

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

  3. Cognitive executive function tests - SDMT

    The symbol-digit modalities test (SDMT) is a symbol substitution neuropsychological test that examines a person's attention and speed of processing. Higher scores will indicate better performance.

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

  4. Physical function

    The short physical performance battery (SPPB) is a group of measures that combines the results of the gait speed, chair stand and balance tests. It has been used as a predictive tool for possible disability and can aid in the monitoring of function in older people. The scores range from 0 (worst performance) to 12 (best performance), aggregated from the different subtests.

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

  5. Motor function

    "Dual task" measure: cost of gait speed reduction when a cognitive task (verbal fluency) is associated during gait, compared to gait alone.

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

  6. Cognitive executive function tests - Digit span

    The digit span is a widely used neuropsychological test to assess attention and working memory.

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

  7. Cognitive executive function tests - Trail Making Test

    Trail Making Test (TMT A and B) will be perform to assess executive function (attention).

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2019
  2. Study start23 Mar 2020
  3. Primary completion23 Mar 2023 (estimated)
  4. Study completion23 Mar 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
93 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04115215
Sponsor's protocol ID
FRONT STAGE (PI19/00734)
Acronym
FRONT STAGE
Status last verified
Jun 2021
First submitted
30 Sep 2019
Last updated
2 Jul 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Physical exercise (PE) and Transcranial current stimulation (tCS) in people with Cognitive Impairment and Motoric Cognitive Risk Syndrome, run by Parc Sanitari Pere Virgili at 5 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in hemoglobin oxygenation during functional tasks, as measured using fNIRS+fDCS optical techniques. (time frame: Baseline (prior to intervention), 3 and 6 months after completion of the intervention.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04115215.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2021.

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