Transcranial Direct Current Stimulation on Post Stroke Depression

May 4, 2026 updated by: Riphah International University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab Province
      • Rawalpindi, Punjab Province, Pakistan, 466000
        • Pakistan Railway General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: tDCS Group
Active tDCS will be applied to the M1 area of the brain with the conventional therapy
Other: 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
Other: Conventional treatment
Breathing exercises will be performed
Active Comparator: Sham tDCS Group
Sham tDCS will be applied to the M1 area of the brain with the conventional therapy
Other: 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
Other: Conventional treatment
Breathing exercises will be performed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 weeks
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.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Mirza Obaid Baig, MSPT, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 25, 2024

Primary Completion (Actual)

August 31, 2025

Study Completion (Actual)

September 10, 2025

Study Registration Dates

First Submitted

September 12, 2024

First Submitted That Met QC Criteria

September 16, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 4, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC02030 Jaweria Zaib Abbasi

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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