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

NCT07346989 | Not Yet Recruiting

• 1 other identifier: 2025-FIS-4007899
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Prefrail Elderly

Keywords

Prefrail; Non-invasive neuromodulation; TMS; TDCS; Virtual running; Functional capacity; Elderly

Outcome Measures

Primary Outcomes (2)

• Frailty Condition

  Fried's criteria (Frailty Phenotype) will be used. Briefly, the participant will be considered frail if he or she meets three or more of the following criteria: i) unintentional weight loss greater than 4.5 kg in the last year; ii) feeling of general exhaustion, reported by the patient himself; iii) low level of physical activity; (iv) slowness of progress; v) muscle weakness, assessed by handgrip strength. Those patients who meet one or two criteria will be considered pre-frail and those who do not meet either will be considered non-frail

  Five assessments: Baseline (T1); After the first session, at Day 1 (T2); Mid-term assessment, 4 weeks after the intervention starts (T3); After the intervention, 8 weeks (T4); Four weeks after the end of the intervention (follow-up assessment) (T5).

• Walking speed

  The 10m Walking Test will be used to assess the speed of the walk, which records the time needed to cover the distance of 10m. The higher the walking speed, the greater the functional capacity

  Five assessments: Baseline (T1); After the first session, at Day 1 (T2); Mid-term assessment, 4 weeks after the intervention starts (T3); After the intervention, 8 weeks (T4); Four weeks after the end of the intervention (follow-up assessment) (T5).

Secondary Outcomes (7)

• Neuroplasticity

  Three assessments: Baseline (T1); After the intervention, 8 weeks (T4); Four weeks after the end of the intervention (follow-up assessment) (T5).

• Heart rate variability

  Five assessments: Baseline (T1); After the first session, at Day 1 (T2); Mid-term assessment, 4 weeks after the intervention starts (T3); After the intervention, 8 weeks (T4); Four weeks after the end of the intervention (follow-up assessment) (T5).

• Muscle strength

  Three assessments: Baseline (T1); After the intervention, 8 weeks (T4); Four weeks after the end of the intervention (follow-up assessment) (T5).

• Quality of life EQ-5D

  Three assessments: Baseline (T1); After the intervention, 8 weeks (T4); Four weeks after the end of the intervention (follow-up assessment) (T5).

• Lower limb muscle power

  Five assessments: Baseline (T1); After the first session, at Day 1 (T2); Mid-term assessment, 4 weeks after the intervention starts (T3); After the intervention, 8 weeks (T4); Four weeks after the end of the intervention (follow-up assessment) (T5).

Study Arms (6)

rTMS group

EXPERIMENTAL

Other: rTMS

rTMS placebo group

PLACEBO COMPARATOR

Other: rTMS placebo

tDCS group

EXPERIMENTAL

Other: tDCS

tDCS placebo group

PLACEBO COMPARATOR

Other: tDCS placebo

VR group

EXPERIMENTAL

Other: Virtual running

VR placebo group

PLACEBO COMPARATOR

Other: Virtual running placebo

Interventions

rTMS OTHER

24 HF-TMS sessions, 3 per week, with a duration of 20 minutes. Magnetic stimulation will be applied using a Neuro-MS/D transcranial magnetic stimulator (Neurosoft ®, Ivanovo, Russia) with a figure-eight coil. The coil will be placed tangentially to the skull in an anteromedial direction at 45º of M1 in the left hemisphere. They will then carry out a therapeutic exercise protocol (common to all groups) that will consist of performing lower limb exercises, including coordination, strength, balance and stretching exercises. The Borg Scale will be used to measure each person's perception of their effort, dyspnea and fatigue during each physical exercise.

rTMS group

rTMS placebo OTHER

The instrumentation will be the same as in the intervention with real rTMS, but the device will not emit any type of electrical stimulus. They will then perform the therapeutic exercise protocol explained above

rTMS placebo group

tDCS OTHER

The tDCS will be performed anodically (a-tDCS), and for 24 sessions, 3 days a week. The electrodes will be mounted on a neoprene helmet, in accordance with the International Standard 10-20 EEG System, for optimal targeting of the primary motor cortex M1. It will be a type of unihemispheric application, in which the anode will be located in the primary motor cortex (M1), and the cathode located in the orbitofrontal cortex contralateral to the anode. The treatment parameters will be: stimulation time of 20 minutes; intensity of 2mA, current rise-fall time at the beginning and end of stimulation of 30 seconds. They will then perform the therapeutic exercise protocol explained above.

tDCS group

tDCS placebo OTHER

The instrumentation will be the same as in the actual tDCS intervention, but the device will be programmed to increase the intensity from 0 to 2 mA progressively during the first 30 seconds and then cease to provide the patient with the initial itchy sensation on the skin, similar to the real application. They will then perform the therapeutic exercise protocol explained above.

tDCS placebo group

Virtual running OTHER

24 sessions will be applied, 3 days a week. The patient will be placed standing (with an ad-hoc designed assistance system) in front of a mirror (located at waist height) and a height-adjustable screen (from waist to caudal) where a video of real legs running on a treadmill will be projected. In order for the participant to feel the projected legs as their own, people with different body sizes will have been previously recorded running to have recordings with legs of different size and length. Each session will last 20 minutes. They will then perform the therapeutic exercise protocol explained above.

VR group

Virtual running placebo OTHER

The instrumentation of the participants will be the same as in the intervention with virtual running. However, the projection will consist of a series of videos of landscapes in which no type of human or animal movement will appear in order not to stimulate the motor areas of the brain. They will then perform the therapeutic exercise protocol explained above.

VR placebo group

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Valencia: lead

Related Publications (3)

• Molla-Casanova S, Page A, Lopez-Pascual J, Ingles M, Sempere-Rubio N, Aguilar-Rodriguez M, Munoz-Gomez E, Serra-Ano P. Effects of mirror neuron activation therapies on functionality in older adults: Systematic review and meta-analysis. Geriatr Nurs. 2024 Mar-Apr;56:115-123. doi: 10.1016/j.gerinurse.2024.02.006. Epub 2024 Feb 11.

  PMID: 38346365 BACKGROUND

• Global Recommendations on Physical Activity for Health. Geneva: World Health Organization; 2010. Available from http://www.ncbi.nlm.nih.gov/books/NBK305057/

  PMID: 26180873 BACKGROUND

• Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.

  PMID: 11253156 BACKGROUND

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Central Study Contacts

Marta Inglés de la Torre, PHD

CONTACT

(9638) 64003; marta.ingles@uv.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: January 16, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: January 16, 2026

Record last verified: 2026-01