Post-stroke DepressionNCT06598670
Transcranial Direct Current Stimulation on Post Stroke Depression
A study testing tDCS and Conventional treatment in people with Post-stroke Depression, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of the research is to address the critical gap that limited number of RCTs are conducted on this topic. To further explore the efficacy of tDCs, large sample sizes, large follow up period and rigorously controlled randomized clinical trials are necessary. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Post-stroke Depression
- What is being tested?
- tDCS and Conventional treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 25 Oct 2024to 10 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stroke for more than 6 months
- Both gender with equal ratio on stroke severity basis
- Depression diagnosed by Psychiatrist
- Mild and moderate Depression at PHQ-9
- National Institutes of Health Stroke Scale (NIHSS) for severity level; Mild (1-4), Moderate (5-15), Moderate to Severe (16-20), Severe (21-42)
Who cannot join
- Any medical condition like cardiac arrhythmias, uncontrolled hypertension.
- Individual with any pacemaker and metal implant in body.
- Patient with any other neurological and psychiatric condition.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Pakistan Railway General Hospital
Rawalpindi, Punjab Province, 466000
About this study
Official title: Effects of Transcranial Direct Current Stimulation on Post Stroke Depression
The aim of the research is to address the critical gap that limited number of RCTs are conducted on this topic. To further explore the efficacy of tDCs, large sample sizes, large follow up period and rigorously controlled randomized clinical trials are necessary. An optimum stimulation protocol is also needed on this study. Previous studies lack information regarding effects of this stimulation on depression, cognition, quality of life in relation to different severity levels of stroke.
Read the detailed description
Research studies revealed that PSD causes both cognitive and physical impairments to lower motivation, which hinders rehabilitation program participation and slows down executive functions. Due to depression, cognitive dysfunctions difficulty in executive, working memory and emotional deficits which declines quality of life (QoL). Thus, the combined effects of cognitive decline and PSD considerably more worsen stroke survivors' QoL with regard to psychological, environmental and physical well-being Evidence supports various techniques for minimizing PSD, restoring cognitive function, and enhancing QoL including mindfulness-based therapies, exercise therapy (aerobic and resistance trainings), progressive muscle relaxation exercises, cognitive behavioral therapy (CBT). Non-invasive brain stimulation (NIBS) include transcranial direct current stimulations (tDCS) demonstrated significant therapeutic outcomes in the PSD rehabilitation.
- Conditions
- Post-stroke Depression
- Being tested
- tDCS, Conventional treatment
- Keywords
- Stroke, depression, transcranial direct current stimulation
- Medical subject headings
- Stroke, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSOther
tDCS will be applied to the M1 area for 20 minutes with 5x7 cm electrodes. The intervention will be applied for eight weeks on alternate days
Conventional treatmentOther
Breathing exercises will be performed
| Study group | Role | What they receive |
|---|---|---|
| tDCS Group | Experimental | Active tDCS will be applied to the M1 area of the brain with the conventional therapy Receives: Other: tDCS; Other: Conventional treatment |
| Sham tDCS Group | Active comparator | Sham tDCS will be applied to the M1 area of the brain with the conventional therapy Receives: Other: tDCS; Other: Conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire (PHQ-9) for depression
Patient Health Questionnaire (PHQ-9) is a self-administered and widely used tool for screening, diagnosing, monitoring, and measuring post stroke depression .It consists of 9 items, scored from 0 (not at all) to 3 (nearly every day), with a total score ranging from 0 to 27. The PHQ-9 interpreted as 0-4=No depression, 5-9=mild depression, 10-14=Moderate depression, 15- 19=Moderately severe, 20-27=severe depression.
Measured: 8 weeks
MoCA
Montreal Cognitive Assessment (MoCA) plays a significant role in the prediction of Cognitive Impairment after stroke. MoCA is scored out of 30 points. Interpreted as 26-30=Normal Cognitive impairment 18-25 = mild cognitive impairment, 10-17= moderate cognitive impairment and less than 10= severe cognitive impairment.
Measured: 8 weeks
Secondary outcomes (1)
SS-QoL
SS-QOL is a tool designed for self-assessment of stroke survivors. It might be completed by the patient or its caregiver, as the time required to complete is 10-15 minutes. The questionnaire consists of 49 items divided in 12 domains; energy, family role, language, mobility, mood, personality, self-care, social role, thinking, upper extremity function, vision and work. Five-point Likert scale. The results are later rescaled to fit the 0 to100 scale where 100 is being the best health state.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start25 Oct 2024
- Primary completion31 Aug 2025
- Study completion10 Sep 2025
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 Post-stroke DepressionStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
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 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06598670
- Sponsor's protocol ID
- REC02030 Jaweria Zaib Abbasi
- Status last verified
- May 2026
- First submitted
- 12 Sep 2024
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chohan SA, Venkatesh PK, How CH. Long-term complications of stroke and secondary prevention: an overview for primary care physicians. Singapore Med J. 2019 Dec;60(12):616-620. doi: 10.11622/smedj.2019158.
PubMed 31889205Sarkar A, Sarmah D, Datta A, Kaur H, Jagtap P, Raut S, Shah B, Singh U, Baidya F, Bohra M, Kalia K, Borah A, Wang X, Dave KR, Yavagal DR, Bhattacharya P. Post-stroke depression: Chaos to exposition. Brain Res Bull. 2021 Mar;168:74-88. doi: 10.1016/j.brainresbull.2020.12.012. Epub 2020 Dec 31.
PubMed 33359639Zhou L, Wang L, Liu G, Cai E. Prognosis prediction models for post-stroke depression: a protocol for systematic review, meta-analysis, and critical appraisal. Syst Rev. 2024 May 22;13(1):138. doi: 10.1186/s13643-024-02544-x.
PubMed 38778417Hao W, Liu Y, Gao Y, Gong X, Ning Y. Transcranial direct current stimulation for the treatment of post-stroke depression: A systematic review. Front Neurol. 2023 Jan 18;13:955209. doi: 10.3389/fneur.2022.955209. eCollection 2022.
PubMed 36742053Herrera-Melendez AL, Bajbouj M, Aust S. Application of Transcranial Direct Current Stimulation in Psychiatry. Neuropsychobiology. 2020;79(6):372-383. doi: 10.1159/000501227. Epub 2019 Jul 24.
PubMed 31340213
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcranial Direct Current Stimulation on Post Stroke Depression
- ClinicalTrials.gov ID
- NCT06598670
- Acronym / sponsor ID
- REC02030 Jaweria Zaib Abbasi
- Conditions
- Post-stroke Depression
- Keywords
- Stroke, depression, transcranial direct current stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 25 Oct 2024 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 10 Sep 2025 (actual)
- First posted
- 19 Sep 2024 (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.
The aim of the research is to address the critical gap that limited number of RCTs are conducted on this topic. To further explore the efficacy of tDCs, large sample sizes, large follow up period and rigorously controlled randomized clinical trials are necessary. An optimum stimulation protocol is also needed on this study. Previous studies lack information regarding effects of this stimulation on depression, cognition, quality of life in relation to different severity levels of stroke.
Detailed description
Research studies revealed that PSD causes both cognitive and physical impairments to lower motivation, which hinders rehabilitation program participation and slows down executive functions. Due to depression, cognitive dysfunctions difficulty in executive, working memory and emotional deficits which declines quality of life (QoL). Thus, the combined effects of cognitive decline and PSD considerably more worsen stroke survivors' QoL with regard to psychological, environmental and physical well-being Evidence supports various techniques for minimizing PSD, restoring cognitive function, and enhancing QoL including mindfulness-based therapies, exercise therapy (aerobic and resistance trainings), progressive muscle relaxation exercises, cognitive behavioral therapy (CBT). Non-invasive brain stimulation (NIBS) include transcranial direct current stimulations (tDCS) demonstrated significant therapeutic outcomes in the PSD rehabilitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tDCS Group | Experimental | Other: tDCS, Other: Conventional treatmentActive tDCS will be applied to the M1 area of the brain with the conventional therapy |
| Sham tDCS Group | Active comparator | Other: tDCS, Other: Conventional treatmentSham tDCS will be applied to the M1 area of the brain with the conventional therapy |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Stroke for more than 6 months
- Both gender with equal ratio on stroke severity basis
- Depression diagnosed by Psychiatrist
- Mild and moderate Depression at PHQ-9
- National Institutes of Health Stroke Scale (NIHSS) for severity level; Mild (1-4), Moderate (5-15), Moderate to Severe (16-20), Severe (21-42)
Key exclusion criteria (3 listed)
- Any medical condition like cardiac arrhythmias, uncontrolled hypertension.
- Individual with any pacemaker and metal implant in body.
- Patient with any other neurological and psychiatric condition.
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 |
|---|---|---|
| tDCStDCS will be applied to the M1 area for 20 minutes with 5x7 cm electrodes. The intervention will be applied for eight weeks on alternate days | Other | Sham tDCS Group, tDCS Group |
| Conventional treatmentBreathing exercises will be performed | Other | Sham tDCS Group, tDCS Group |
Primary outcome
Patient Health Questionnaire (PHQ-9) for depression
Time frame: 8 weeks
Patient Health Questionnaire (PHQ-9) is a self-administered and widely used tool for screening, diagnosing, monitoring, and measuring post stroke depression .It consists of 9 items, scored from 0 (not at all) to 3 (nearly every day), with a total score ranging from 0 to 27. The PHQ-9 interpreted as 0-4=No depression, 5-9=mild depression, 10-14=Moderate depression, 15- 19=Moderately severe, 20-27=severe depression.
MoCA
Time frame: 8 weeks
Montreal Cognitive Assessment (MoCA) plays a significant role in the prediction of Cognitive Impairment after stroke. MoCA is scored out of 30 points. Interpreted as 26-30=Normal Cognitive impairment 18-25 = mild cognitive impairment, 10-17= moderate cognitive impairment and less than 10= severe cognitive impairment.
1 secondary outcome
SS-QoL
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Background: PubMed 31889205Chohan SA, Venkatesh PK, How CH. Long-term complications of stroke and secondary prevention: an overview for primary care physicians. Singapore Med J. 2019 Dec;60(12):616-620. doi: 10.11622/smedj.2019158.
- Background: PubMed 33359639Sarkar A, Sarmah D, Datta A, Kaur H, Jagtap P, Raut S, Shah B, Singh U, Baidya F, Bohra M, Kalia K, Borah A, Wang X, Dave KR, Yavagal DR, Bhattacharya P. Post-stroke depression: Chaos to exposition. Brain Res Bull. 2021 Mar;168:74-88. doi: 10.1016/j.brainresbull.2020.12.012. Epub 2020 Dec 31.
- Background: PubMed 38778417Zhou L, Wang L, Liu G, Cai E. Prognosis prediction models for post-stroke depression: a protocol for systematic review, meta-analysis, and critical appraisal. Syst Rev. 2024 May 22;13(1):138. doi: 10.1186/s13643-024-02544-x.
- Background: PubMed 36742053Hao W, Liu Y, Gao Y, Gong X, Ning Y. Transcranial direct current stimulation for the treatment of post-stroke depression: A systematic review. Front Neurol. 2023 Jan 18;13:955209. doi: 10.3389/fneur.2022.955209. eCollection 2022.
- Background: PubMed 31340213Herrera-Melendez AL, Bajbouj M, Aust S. Application of Transcranial Direct Current Stimulation in Psychiatry. Neuropsychobiology. 2020;79(6):372-383. doi: 10.1159/000501227. Epub 2019 Jul 24.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Mirza Obaid Baig, 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 and Conventional treatment in people with Post-stroke Depression, 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 8 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire (PHQ-9) for depression (time frame: 8 weeks). The study lists 2 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 NCT06598670, 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 8 May 2026.