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

Official title

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

Overview

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.

Detailed description

Two non-invasive neuromodulation strategies (Virtual Running and Transcranial Direct Current Stimulation (tDCS)) will be studied. Thus, 2 sub-studies will be carried out (one for each intervention) and a comparison of the two 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.

Interventions

• Other tDCS
  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 t
• Other tDCS placebo
  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.
• Other Virtual running
  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. E
• Other Virtual running placebo
  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.

Primary outcome measures

• Frailty Condition [Time frame: 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 [Time frame: 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 outcome measures (7)

• Neuroplasticity [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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).]
• Static and dynamic functionality and gait quality [Time frame: 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).]
• Static and dynamic functionality and gait quality with a dual task [Time frame: Three assessments: Baseline (T1); After the intervention, 8 weeks (T4); Four weeks after the end of the intervention (follow-up assessment) (T5).]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

Spain · 1 center

• University of Valencia — Valencia

Publications

• 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
• Global Recommendations on Physical Activity for Health. Geneva: World Health Organization; 2010. Available from http://www.ncbi.nlm.nih.gov/books/NBK305057/ PMID 26180873
• 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

Identifiers

NCT: NCT07346989 · 2025-FIS-4007899

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗