Transcranial Direct Current Stimulation on Post Stroke Depression

NCT06598670 | Recruiting

• 1 other identifier: REC02030 Jaweria Zaib Abbasi
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-stroke Depression

Keywords

Stroke; depression; transcranial direct current stimulation

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  8 weeks

Secondary Outcomes (1)

• SS-QoL

  8 weeks

Study Arms (2)

tDCS Group

EXPERIMENTAL

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

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

Other: tDCS; Other: Conventional treatment

Interventions

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

Sham tDCS Group; tDCS Group

Conventional treatment OTHER

Breathing exercises will be performed

Sham tDCS Group; tDCS Group

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Pakistan Railway General Hospital

Rawalpindi, Punjab Province, 466000, Pakistan

RECRUITING

Related Publications (5)

• 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.

  PMID: 31889205 BACKGROUND

• 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.

  PMID: 33359639 BACKGROUND

• 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.

  PMID: 38778417 BACKGROUND

• 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.

  PMID: 36742053 BACKGROUND

• 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.

  PMID: 31340213 BACKGROUND

MeSH Terms

Conditions

Stroke; Depression

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Mirza Obaid Baig, MSPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jaweria Zaib Abbasi, DPT

CONTACT

00923114056900; jaweriaabbasi800@gmail.com

Mirza Obaid Baig, MSPT

CONTACT

00923332238706; obaid.baig@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2024
• First Posted: September 19, 2024
• Study Start: October 25, 2024
• Primary Completion: June 30, 2025
• Study Completion: July 31, 2025
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)