Clinical trial NCT06598670: Transcranial Direct Current Stimulation on Post Stroke Depression
Official title: Effects of Transcranial Direct Current Stimulation on Post Stroke Depression
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post-stroke Depression
Keywords: Stroke
depression
transcranial direct current stimulation
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 56
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Patient Health Questionnaire (PHQ-9) for depression
timeFrame: 8 weeks
measure: MoCA
timeFrame: 8 weeks
Secondary outcomes:
measure: SS-QoL
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Pakistan Railway General Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Mirza Obaid Baig, MSPT
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.