Community-dwelling ElderlyNCT07573800
tDCS and the Cardiovascular System in Community-dwelling Elderly.
A study testing tDCS in people with Community-dwelling Elderly, run by Riphah International University at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Community-dwelling Elderly
- What is being tested?
- tDCS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 sitePakistan
- Study dates
- May 2026to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to ambulate independently (with or without assistive device)
- Cognitively intact (MoCA score ≥ 24)
- PAR-Q
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Pakistan Railway Hospital
Rawalpindi, Punjab Province
Nimra Irshad, DPT, 00923157338975, nimrairshad225@gmail.com
Sumaiyah Obaid, MSPT, 00923212683462, sumaiyah.obaid@riphah.edu.pk
About this study
Official title: 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.
Read the 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.
- Conditions
- Community-dwelling Elderly
- Being tested
- tDCS, Sham stimulation
- Keywords
- tDCS, cardiovascular, locomotor units, community-dwellers, elderly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSOther
The focal electrodes of 25-35 cm² will be placed on M1, identifying via the 10/20 EEG system.
Sham stimulationOther
Sham stimulation of the M1 area by using the 25-35 square centimeter electrodes.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Not described Receives: Other: tDCS; Other: Sham stimulation |
| Group 2 | Sham comparator | Not described Receives: Other: tDCS; Other: Sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: baseline, week 1, and 5
Secondary outcomes (1)
tDCS Safety Screening Questionnaire
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.
Measured: baseline, week 1, and 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study startMay 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Community-dwelling ElderlyStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mirza Obaid Baig, MSPT, Principal investigator, Riphah International UniversitySumaiyah Obaid, MSPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07573800
- Sponsor's protocol ID
- REC02295 Nimra Irshad
- Status last verified
- Apr 2026
- First submitted
- 30 Apr 2026
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33423544da 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.
PubMed 37974293Choi 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.
PubMed 40613366Keller-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.
PubMed 33337767Bornheim 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.
PubMed 32394750
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assess Transcranial Direct Current Stimulation for Cardiovascular and Locomotor Outcomes in the Community-dwellers
- ClinicalTrials.gov ID
- NCT07573800
- Acronym / sponsor ID
- REC02295 Nimra Irshad
- Conditions
- Community-dwelling Elderly
- Keywords
- tDCS, cardiovascular, locomotor units, community-dwellers, elderly
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 7 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: tDCS, Other: Sham stimulation |
| Group 2 | Sham comparator | Other: tDCS, Other: Sham stimulation |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Able to ambulate independently (with or without assistive device)
- Cognitively intact (MoCA score ≥ 24)
- PAR-Q
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tDCSThe focal electrodes of 25-35 cm² will be placed on M1, identifying via the 10/20 EEG system. | Other | Group 1, Group 2 |
| Sham stimulationSham stimulation of the M1 area by using the 25-35 square centimeter electrodes. | Other | Group 1, Group 2 |
Primary outcome
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
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.
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
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.
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.
1 secondary outcome
tDCS Safety Screening Questionnaire
Time frame: baseline, week 1, and 5
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Background: PubMed 33423544Rodrigues 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.
- Background: PubMed 37974293da 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.
- Background: PubMed 40613366Choi 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.
- Background: PubMed 33337767Keller-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.
- Background: PubMed 32394750Bornheim 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.
- Individual participant dataSharing planned: No
Related trials for Community-dwelling Elderly
Not yet recruiting
Motor Imagery and Turning Practice to Improve Mobility: Pilot Trial
Mobility Impairment, Community Dwelling Older Adults
Not yet recruiting
Comparative Effects of Exercises on Reactive Balance and Fall Risk in Community-Dwelling Older Adults
COMMUNITY-DWELLING OLDER ADULTS
Enrolling by invitationObservational study
Comorbidity, Cognition, Gait Speed, and Respiratory Muscle Strength in Older Adults
Geriatrics, Older Adults (60 - 85 Years Old)
Not yet recruiting
Multicomponent Exercise and Pain Science Education for Fall Prevention in Older Adults With Chronic Musculoskeletal Pain (MovePainFall)
Chronic Pain, Musculoskeletal Pain
Not yet recruiting
Eccentric Exercise in Community-dwelling Older Adults
Ageing Well
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mirza Obaid Baig, MSPT principal investigator
Riphah International University
Sumaiyah Obaid, MSPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS in people with Community-dwelling Elderly, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nimra Irshad, DPT (00923157338975, nimrairshad225@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
10-Meter Walk Test (10MWT) (time frame: baseline, week 1, and week 5). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07573800, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.