Effect of tDCS on Inflammatory Biomarkers in Chronic Schizophrenia

Not Applicable

Recruiting

• Conditions: Chronic Schizophrenia

• Registration Number: NCT06349369
• Lead Sponsor: All India Institute of Medical Sciences, Bhubaneswar

Brief Summary

The study is a randomized, double-blind, parallel-arm, sham-controlled trial that aims to compare the effects of transcranial direct current stimulation (tDCS) versus sham stimulation on inflammatory markers (IL-6 and TNF-alpha) and clinical outcomes (PANSS, AHRS, CGI-SCH, GAF) in patients with chronic schizophrenia over 10 days of treatment. The primary objective is to assess changes in IL-6 levels, while secondary objectives include evaluating changes in TNF-alpha, symptom scales, and adverse events. The study will be conducted at the psychiatry department of AIIMS Bhubaneswar, with 60 patients aged 18-60 years with moderate-to-severe schizophrenia symptoms randomized to receive either active tDCS (cathode over left temporo-parietal junction, anode over left dorsolateral prefrontal cortex) or sham stimulation. The researchers hope to elucidate the potential immunomodulatory effects of tDCS and its impact on symptoms in chronic schizophrenia, which may lead to more targeted, multifaceted interventions to improve patient outcomes.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-01
• Study First Submitted QC: 2024-04-01
• Study First Posted: 2024-04-05
• Study Start: 2024-04-08
• Last Update Submitted: 2024-04-24
• Last Update Posted: 2024-04-25
• Primary Completion: 2025-12-09
• Study Completion: 2026-04-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 1. Patients clinically diagnosed with schizophrenia (F20 according to ICD-11) for a period more than 2 years receiving antipsychotics.

2. Moderate to severe symptoms (PANSS score >75 and/or CGI-SGH score >4) 3. Patients of both sex 18-60 years 4. Right-handed. 5. Legally authorized representative (LAR) giving voluntary written consent for participation in the study.

Exclusion Criteria

• 1. Patients with chance of pregnancy. 2. Any psychiatric emergency (e.g. suicidal risk, catatonia, prolonged nutritional deprivation) or others (e.g.: aggression or excitement) 3. Co-morbid neurological disease: i) History of migraine. ii) History of seizure/epilepsy. iii) History of head trauma or organic disease.

  2. Any contraindication to tDCS procedure: i) Injury or local lesion in the scalp/head ii) Metallic implants in the head iii) Implanted brain medical devices 5. Left-handed.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in the IL-6 levels	10 days

Secondary Outcome Measures

Name	Time	Method
Change in the Positive and Negative syndrome Scale	5 days and 10 days	score 1- absent symptoms Score 7- extreme symptoms
Change in the Auditory hallucination rating scale	5 days and 10 days	score 0- No Auditory hallucination Score 9- Severe Auditory hallucination
Change in the Clinical global impression- Schizophrenia scale	5 days and 10 days	score 0- not assessed score 7- extremely ill patients
To compare the adverse events reported in both control and intervention groups.	5 days and 10 days
Change in the TNF alpha levels.	10 days
Change in the Global Assessment of Functioning scale	5 days and 10 days	score 0- inadequate information score 100- No symptoms

Trial Locations

Locations (1)

AIIMS Bhubaneswar; 🇮🇳 Bhubaneswar, Odisha, India