Transcranial Direct Current Stimulation on Post Stroke Depression

NCT ID: NCT06598670

Last Updated: 2025-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-25

Study Completion Date

2025-07-31

Brief Summary

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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

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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

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Post-stroke Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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tDCS Group

Active tDCS will be applied to the M1 area of the brain with the conventional therapy

Group Type EXPERIMENTAL

tDCS

Intervention Type OTHER

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 treatment

Intervention Type OTHER

Breathing exercises will be performed

Sham tDCS Group

Sham tDCS will be applied to the M1 area of the brain with the conventional therapy

Group Type ACTIVE_COMPARATOR

tDCS

Intervention Type OTHER

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 treatment

Intervention Type OTHER

Breathing exercises will be performed

Interventions

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tDCS

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

Intervention Type OTHER

Conventional treatment

Breathing exercises will be performed

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

* 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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Riphah International University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mirza Obaid Baig, MSPT

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

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Pakistan Railway General Hospital

Rawalpindi, Punjab Province, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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Jaweria Zaib Abbasi, DPT

Role: CONTACT

00923114056900

Mirza Obaid Baig, MSPT

Role: CONTACT

00923332238706

Facility Contacts

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Jaweria Zaib Abbasi, DPT

Role: primary

00923114056900

Mirza Obaid Baig, MSPT

Role: backup

0092 333 2238706

References

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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.

Reference Type BACKGROUND
PMID: 31889205 (View on PubMed)

Sarkar 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.

Reference Type BACKGROUND
PMID: 33359639 (View on PubMed)

Zhou 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.

Reference Type BACKGROUND
PMID: 38778417 (View on PubMed)

Hao 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.

Reference Type BACKGROUND
PMID: 36742053 (View on PubMed)

Herrera-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.

Reference Type BACKGROUND
PMID: 31340213 (View on PubMed)

Other Identifiers

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REC02030 Jaweria Zaib Abbasi

Identifier Type: -

Identifier Source: org_study_id

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