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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2028-07-31

Brief Summary

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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.

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RECRUITING PHASE2

Detailed Description

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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.

Conditions

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Prefrail Elderly

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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rTMS group

Group Type EXPERIMENTAL

rTMS

Intervention Type 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 placebo group

Group Type PLACEBO_COMPARATOR

rTMS placebo

Intervention Type 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

tDCS group

Group Type EXPERIMENTAL

tDCS

Intervention Type 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 placebo group

Group Type PLACEBO_COMPARATOR

tDCS placebo

Intervention Type 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.

VR group

Group Type EXPERIMENTAL

Virtual running

Intervention Type 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 placebo group

Group Type PLACEBO_COMPARATOR

Virtual running placebo

Intervention Type 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.

Interventions

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rTMS

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.

Intervention Type OTHER

rTMS placebo

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

Intervention Type 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 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.

Intervention Type 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.

Intervention Type 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. Each session will last 20 minutes. They will then perform the therapeutic exercise protocol explained above.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

65 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No