Transcranial Direct Current Stimulation on Post Stroke Depression

Not Applicable

Not yet recruiting

• Conditions: Post-stroke Depression
• Interventions: Other: tDCS; Other: Conventional treatment

• Registration Number: NCT06598670
• Lead Sponsor: Riphah International University

Brief 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. 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 Timeline

• Study First Submitted: 2024-09-12
• Study First Submitted QC: 2024-09-16
• Study First Posted: 2024-09-19
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-23
• Study Start: 2024-10-25
• Last Update Posted: 2024-10-26
• Primary Completion: 2025-06-30
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 56

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)

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham tDCS Group	Conventional treatment	Sham tDCS will be applied to the M1 area of the brain with the conventional therapy
Sham tDCS Group	tDCS	Sham tDCS will be applied to the M1 area of the brain with the conventional therapy
tDCS Group	tDCS	Active tDCS will be applied to the M1 area of the brain with the conventional therapy
tDCS Group	Conventional treatment	Active tDCS will be applied to the M1 area of the brain with the conventional therapy

Primary Outcome Measures

Name	Time	Method
Patient Health Questionnaire (PHQ-9) for depression	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	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 Outcome Measures

Name	Time	Method
SS-QoL	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.

Trial Locations

Locations (1)

Pakistan Railway General Hospital; 🇵🇰 Rawalpindi, Punjab, Pakistan