Non-invasive Brain Stimulation on Functional Capacity in Prefrail Older Adults (NeuroFit)

University of Valencia

Status: Not yet enrolling

Conditions: Prefrail Elderly

Treatments: Other: tDCS placebo; Other: Virtual running placebo; Other: rTMS placebo; Other: tDCS; Other: rTMS; Other: Virtual running

Study type: Interventional

Funder types: Other

Identifiers

NCT07346989

2025-FIS-4007899

Details and patient eligibility

About

The general objective of this study is to evaluate the effectiveness of non-invasive neuromodulation combined with a therapeutic exercise program on neuroplasticity and, therefore, on variables related to functional capacity and quality of life, in prefrail older adults.

Full description

Three non-invasive neuromodulation strategies (Virtual Running, Transcranial Magnetic Stimulation (TMS) and Transcranial Direct Current Stimulation (tDCS)) will be studied. Thus, 3 sub-studies will be carried out (one for each intervention) and a comparison of the three interventions will be made, as described in the following sections. As specific objectives, for each of these sub-studies, the effect of the intervention program will be analyzed on: gait speed, general physical condition, frailty condition, static and dynamic functionality and gait quality, upper limb and lower limb isometric strength, quality of life, and neuroplasticity, in terms of plasma BDNF levels, in prefrail older adults.

Enrollment: 120 estimated patients

Sex: All

Ages: 65 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age between 65 -90 years old
• Meet 1-2 frailty criteria, according to Fried's Criteria.
• Ability to understand instructions (Mini-Mental State Examination >23 points).
• Signing of the informed consent.

Exclusion criteria

• History of stroke within the past 6 months or hospital admission for any reason within the past 3 months.
• Alterations of the central or peripheral nervous system
• Alterations of the vestibular system
• Concomitant diseases
• Have a neurological pathology, cardiovascular musculoskeletal that contraindicates physical activity
• Epilepsy or history, medications that lower the seizure threshold
• Cardiac pacemaker, endocranial and hearing implants
• History of severe headaches
• Uncontrolled intracranial or arterial hypertension
• Heart and/or respiratory failure
• Implanted medication pump
• Skin lesions (psoriasis, eczema)
• Serious head surgeries
• Completing less than 80% of training sessions

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 6 patient groups, including a placebo group

rTMS group

Experimental group

Treatment:

Other: rTMS

rTMS placebo group

Placebo Comparator group

Treatment:

Other: rTMS placebo

tDCS group

Experimental group

Treatment:

Other: tDCS

tDCS placebo group

Placebo Comparator group

Treatment:

Other: tDCS placebo

VR group

Experimental group

Treatment:

Other: Virtual running

VR placebo group

Placebo Comparator group

Treatment:

Other: Virtual running placebo