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Completed

NCT Number: NCT06598670

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.

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Key information

Conditions

Post-stroke Depression Behavior Behavioral Symptoms Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Depression Nervous System Diseases Stroke Vascular Diseases

Age range

25 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pakistan Railway General Hospital

Rawalpindi, Punjab Province, 466000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

tDCS

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

Other

Breathing exercises will be performed

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. SS-QoL

    Time frame: 8 weeks

    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.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effects of Transcranial Direct Current Stimulation on Post Stroke Depression

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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