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NCT Number: NCT07573800

tDCS and the Cardiovascular System in Community-dwelling Elderly.

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.

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Key information

Conditions

Community-dwelling Elderly

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

tDCS

Other

The focal electrodes of 25-35 cm² will be placed on M1, identifying via the 10/20 EEG system.

Sham stimulation

Other

Sham stimulation of the M1 area by using the 25-35 square centimeter electrodes.

Primary outcomes

  1. 10-Meter Walk Test (10MWT)

    Time frame: baseline, week 1, and week 5

    The 10MWT is broadly used in preventive care and rehabilitation centers; it is evaluated by measuring participant speed and counting the number of steps taken within a given time period. This measurement method includes walking a certain section set on a smooth floor at the normal or maximum speed. After this, walking time and number of steps taken are to be measured

  2. Blood Pressure Monitor

    Time frame: baseline, week 1, and week 5

    A sphygmomanometer is used to measure systolic and diastolic blood pressure before and after intervention sessions. The modified sphygmomanometer showed excellent test-retest reliability with an intraclass correlation coefficient (ICC) of 0.996.

  3. 6-Minute Walk Test (6MWT)

    Time frame: baseline, week 1, and 5

    It is a sub-maximal exercise test used to assess aerobic capacity and endurance. Any change in performance capacity are determined based on the distance covered in six minutes. The 6MWT is a practically performed simple test that requires a 100-ft hallway but no exercise equipment needed. It helps to evaluates the global and integrated responses of all the systems involved during exercise, including the cardiovascular and pulmonary systems, systemic and peripheral circulation, blood, neuromuscular units, and muscle metabolism

  4. Short Physical performance battery

    Time frame: baseline, week 1, and 5

    It consists of 3 timed components: 1) a 4-m usual pace walk, 2) a 5-repetition chair stand without using one's arms, and 3) a progressive test of standing balance. It is an objective measurement instrument of balance, lower extremity strength, and functional capacity in older adults. The final total SPPB scores ranged between 4 and 12, with 4 to 6 representing the low, 7 to 9 the middle, and 10 to 12 the best performance.

  5. Heart rate variability (HRV)

    Time frame: baseline, week 1, and 5

    Heart Rate Variability (HRV) in community-dwellers is a critical, non-invasive marker of autonomic nervous system function, with lower HRV values consistently predicting higher cardiovascular risk, mortality, and functional decline. Among community-dwelling older adults, reduced HRV is strongly associated with adverse health outcomes such as frailty, cognitive impairment, and depression.

Secondary outcomes

  1. tDCS Safety Screening Questionnaire

    Time frame: baseline, week 1, and 5

    Used to assess the safety and suitability of participants for tDCS intervention by assessing different potential risks. It includes medical history, medication, skin sensitivities, neurological conditions, and mental health.

Study contacts

Contact information is provided by the study sponsor or research team.

Mirza Obaid Baig, MSPT

CONTACT

[email protected]

00923332238706

Nimra Irshad, DPT

CONTACT

[email protected]

00923157338975

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
May 7, 2026
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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