tDCS and the Cardiovascular System in Community-dwelling Elderly.

NCT07573800 | Not Yet Recruiting

• 1 other identifier: REC02295 Nimra Irshad
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Community-dwelling Elderly

Keywords

tDCS; cardiovascular; locomotor units; community-dwellers; elderly

Outcome Measures

Primary Outcomes (5)

• 10-Meter Walk Test (10MWT)

  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

  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)

  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

  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)

  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 Outcomes (1)

• tDCS Safety Screening Questionnaire

  baseline, week 1, and 5

Study Arms (2)

Group 1

EXPERIMENTAL

Other: tDCS; Other: Sham stimulation

Group 2

SHAM COMPARATOR

Other: tDCS; Other: Sham stimulation

Interventions

tDCS OTHER

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

Group 1; Group 2

Sham stimulation OTHER

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

Group 1; Group 2

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Pakistan Railway Hospital

Rawalpindi, Punjab Province, Pakistan

Location

Related Publications (5)

• 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 BACKGROUND

• 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/s13063-023-07694-2.

  PMID: 37974293 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Mirza Obaid Baig, MSPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

• Sumaiyah Obaid, MSPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nimra Irshad, DPT

CONTACT

00923157338975; nimrairshad225@gmail.com

Mirza Obaid Baig, MSPT

CONTACT

00923332238706; obaid.baig@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: May 7, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: May 7, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)