tDCS and the Cardiovascular System in Community-dwelling Elderly.

Официальное название

Assess Transcranial Direct Current Stimulation for Cardiovascular and Locomotor Outcomes in the Community-dwellers

Обзор

This study could contribute to the advancements in healthcare by exploring the innovative intervention, which is Transcranial Direct Current Stimulation (tDCS). Investigating its impact on cardiovascular and locomotor outcomes could give rise to new non-pharmacological interventions for health promotion, disease prevention, and rehabilitation.

Подробное описание

Age-related functional decline occurs in various organs like the cardiovascular system, brain, muscles, lungs, kidneys, and immune system in the body, contributing significantly to the onset of frailty in elderly individuals. Due to routine degeneration of aging, physical impairments related to movement take place, which include strength, balance, gait, and performance issues (5).

Cardiovascular autonomic regulation is considered an important factor in health, while the autonomic nervous system is important for adapting therapy for prolonged cardiovascular outcomes.

The process of aging can produce pathological changes in the cardiovascular system, whose results may lead to CVD. One of the main changes of aging is the augmented stiffness of central arteries, known as vascular aging. It occurs due to loss of elastic fibers and accumulation of collagen in the major elastic arteries, which leads to an increase in systolic and pulse pressures of healthy elderly individuals. These hemodynamic changes in vessels lead to clinical illness and increase the risk of developing hypertension, atherosclerosis, and stroke. While some other studies have shown that aging is also related to continuous decline in exercise capacity, walking ability, and physical function, impacting the performance of daily activity and maintaining personal independence. Walking limitation is very frequent in the elderly population, estimated at 58.1% to 93.2%, which can be a functional dependence risk factor among community dwellers. While increasing walking ability impacts several aspects of health-related quality of life, including physical, social, and emotional well-being.

tDCS has a considerable impact on neuroplasticity and hypotension by delivering new interventional strategies to control blood pressure.

Вмешательства

• Другое tDCS
  The focal electrodes of 25-35 cm² will be placed on M1, identifying via the 10/20 EEG system.
• Другое Sham stimulation
  Sham stimulation of the M1 area by using the 25-35 square centimeter electrodes.

Первичные конечные точки

• 10-Meter Walk Test (10MWT) [Срок оценки: baseline, week 1, and week 5]
• Blood Pressure Monitor [Срок оценки: baseline, week 1, and week 5]
• 6-Minute Walk Test (6MWT) [Срок оценки: baseline, week 1, and 5]
• Short Physical performance battery [Срок оценки: baseline, week 1, and 5]
• Heart rate variability (HRV) [Срок оценки: baseline, week 1, and 5]

Вторичные конечные точки (1)

• tDCS Safety Screening Questionnaire [Срок оценки: baseline, week 1, and 5]

Критерии участия

Критерии включения

• Able to ambulate independently (with or without assistive device)
• Cognitively intact (MoCA score ≥ 24)
• PAR-Q

Критерии исключения

• History of seizures or epilepsy
• Implanted metallic or electronic devices (e.g., pacemakers, ICD)
• Uncontrolled hypertension (>180/110 mmHg)
• Severe cardiac, pulmonary, neurological, or orthopedic disorders limiting participation
• Active skin conditions at electrode sites
• Recent hospitalization (<3 months)
• Ongoing hormonal therapy, anticoagulants, or psychotropic medications

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Пакистан · 1 центр

• Pakistan Railway Hospital — Rawalpindi

Публикации

• Rodrigues B, Barboza CA, Moura EG, Ministro G, Ferreira-Melo SE, Castano JB, Ruberti OM, De Amorim RFB, Moreno H Junior. Transcranial direct current stimulation modulates autonomic nervous system and reduces ambulatory blood pressure in hypertensives. Clin Exp Hypertens. 2021 May 19;43(4):320-327. doi: 10.1080/10641963.2021.1871916. Epub 2021 Jan 11. PMID 33423544
• da Silva VCC, da Silva Areas FZ, Lopes ALRB, de Almeida E Val FF, da Costa AG, Dos Santos JCC, Ferreira JMBB, Peixoto Tinoco Areas G. Anodal transcranial direct current stimulation associated with aerobic exercise on the functional and physical capacity of patients with heart failure with reduced ejection fraction: ELETRIC study protocol. Trials. 2023 Nov 17;24(1):738. doi: 10.1186/s13063-023-0769 PMID 37974293
• Choi BJ, Lee H, Kang N. Does Transcranial Direct Current Stimulation Improve Gait Performances in Healthy Older Adults? A Meta-Analysis. J Integr Neurosci. 2025 Jun 19;24(6):36636. doi: 10.31083/JIN36636. PMID 40613366
• Keller-Ross ML, Chantigian DP, Nemanich S, Gillick BT. Cardiovascular Effects of Transcranial Direct Current Stimulation and Bimanual Training in Children With Cerebral Palsy. Pediatr Phys Ther. 2021 Jan 1;33(1):11-16. doi: 10.1097/PEP.0000000000000762. PMID 33337767
• Bornheim S, Thibaut A, Beaudart C, Maquet P, Croisier JL, Kaux JF. Evaluating the effects of tDCS in stroke patients using functional outcomes: a systematic review. Disabil Rehabil. 2022 Jan;44(1):13-23. doi: 10.1080/09638288.2020.1759703. Epub 2020 May 12. PMID 32394750

Идентификаторы

NCT: NCT07573800 · REC02295 Nimra Irshad

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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