Brain Stimulation for Foot-sole Sensation in Older Adults With Foot-sole Somatosensory Deficits

Официальное название

Cortical Mechanisms and Modulation of Somatosensation in Older Adults With Foot Sole Somatosensory Impairments

Обзор

In older adults, diminished sensation of the legs and feet is highly prevalent and causes poor balance and reduced mobility. This type of sensation is not only dependent upon the receptors and nerves in the legs and feet, but also upon a complex central nervous system pathway that includes the cerebral cortex of the brain. This project will use a form of noninvasive brain stimulation called transcranial direct current stimulation (tDCS) to test whether increasing the excitability of the brain networks that process sensory feedback can augment foot sole sensation, balance, and mobility in older adults suffering from mild-to-moderate foot sole sensory impairments.

Вмешательства

• Устройство transcranial direct current stimulation
  tDCS can safely and selectively modulate cortical excitability (specifically neuronal firing likelihood) by transferring weak electrical currents between scalp electrodes. The direct current delivered by any one electrode will not exceed 2.0 mA and the total amount of current from all electrodes will not exceed 4 mA in this study.
• Устройство active sham stimulation
  sham stimulation will implement the same protocol of the tDCS intervention; however, only very low-level currents (no more than 0.5 mA) are transferred between the same electrodes used for the tDCS throughout the 20-minute session. This strategy effectively mimics the cutaneous sensations and skin redness induced by creating only micro cortical electric fields.

Первичные конечные точки

• postural sway area when standing with eyes closed on the foam [Срок оценки: Before and immediately after intervention]
• Timed Up-and-Go (TUG) time [Срок оценки: Before and immediately after intervention]
• On-target Blood oxygen level dependent (BOLD) signal intensity in response to foot sole stimulation [Срок оценки: Before and immediately after intervention]
• Standing vibratory thresholds of each foot sole [Срок оценки: Before and immediately after intervention]

Вторичные конечные точки (2)

• Postural sway speed when standing with eyes closed on the foam [Срок оценки: Before and immediately after intervention]
• Gait speed of 10m walking test [Срок оценки: Before and immediately after intervention]

Критерии участия

Критерии включения

• Aged ≥65 years.
• Self-reported feeling of unsteadiness or difficulty when standing and walking.
• Mild-to-moderate foot-sole somatosensory impairment: the ability to perceive 75g monofilament but inability to perceive 10g monofilament.

Критерии исключения

• self-reported inability to stand or walk continuously for one minute without personal assistance (canes or walkers allowed);
• history or presence of foot ulceration, amputation, or deformities;
• self-reported uncontrolled pain or pain that is associated with mobility disability;
• uncontrolled diabetes mellitus;
• hospitalization within the past three months due to acute illness, or as the result of a musculoskeletal injury significantly affecting balance;
• persistent severe pain of lower extremity when standing or walking;
• diagnosis of dementia, Parkinson's disease, or stroke that affects balance;
• unstable medical condition;
• legal blindness or deafness;
• uncontrolled hypertension (i.e., systolic BP >180, diastolic BP >100 mm Hg, or prescription of ≥3 anti-hypertensive medications);
• functionally limiting nephropathy, severe diseases or transplant of the kidney or liver, renal or congestive heart failure;
• active cancer treatment;
• balance disorders due to past use of chemotherapy or history of Guillain-Barré syndrome;
• use of neuro-active or recreational drugs (e.g., sedatives, anti-psychotics), or alcohol abuse, which may affect the brain excitability;
• contraindications to MRI or tDCS (e.g., personal or family history of seizures or epilepsy, metallic or electric bio-implants, claustrophobia, brain surgery);
• persistent vertigo;
• history of Charcot-Marie-Tooth nerve disease.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Hebrew SeniorLife — Roslindale

Идентификаторы

NCT: NCT06771531 · Pro00044674 · K01AG075180

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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