tDCS and the Cardiovascular System in Community-dwelling Elderly.

April 30, 2026 updated by: Riphah International University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Pakistan
    • Punjab Province
      • Rawalpindi, Punjab Province, Pakistan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
Other: tDCS
The focal electrodes of 25-35 cm² will be placed on M1, identifying via the 10/20 EEG system.
Other: Sham stimulation
Sham stimulation of the M1 area by using the 25-35 square centimeter electrodes.
Sham Comparator: Group 2
Other: tDCS
The focal electrodes of 25-35 cm² will be placed on M1, identifying via the 10/20 EEG system.
Other: Sham stimulation
Sham stimulation of the M1 area by using the 25-35 square centimeter electrodes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline, week 1, and week 5
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.
baseline, week 1, and week 5
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
baseline, week 1, and 5
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.
baseline, week 1, and 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.
baseline, week 1, and 5

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline, week 1, and 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Sumaiyah Obaid, MSPT, Riphah International University
  • Principal Investigator: Mirza Obaid Baig, MSPT, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

January 31, 2027

Study Registration Dates

First Submitted

April 30, 2026

First Submitted That Met QC Criteria

April 30, 2026

First Posted (Actual)

May 7, 2026

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

April 30, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC02295 Nimra Irshad

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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