Transcranial Direct Current Stimulation on Post Stroke Depression

Riphah International University

Status: Enrolling

Conditions: Post-stroke Depression

Treatments: Other: tDCS; Other: Conventional treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT06598670

REC02030 Jaweria Zaib Abbasi

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 estimated patients

Sex: All

Ages: 25 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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56 participants in 2 patient groups

tDCS Group

Experimental group

Description:

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

Treatment:

Other: Conventional treatment

Other: tDCS

Sham tDCS Group

Active Comparator group

Description:

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

Treatment:

Other: Conventional treatment

Other: tDCS