Effects of brain stimulation on inflammation in chronic schizophrenia
Effect of Transcranial Direct Current Stimulation (tDCS) on Inflammatory Biomarkers in Chronic Schizophrenia: A Randomised Double-Blind Controlled Trial.
This study is testing if a type of brain stimulation can lower inflammation and improve symptoms in people with chronic schizophrenia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | All India Institute of Medical Sciences, Bhubaneswar Academic / other |
| Locations | 1 site (Bhubaneswar, Odisha) |
| Trial ID | NCT06349369 on ClinicalTrials.gov |
What this trial studies
This study is a randomized, double-blind, parallel-arm, sham-controlled trial that investigates the impact of transcranial direct current stimulation (tDCS) on inflammatory markers and clinical outcomes in patients with chronic schizophrenia. Over a 10-day treatment period, 60 patients aged 18-60 with moderate to severe symptoms will be randomized to receive either active tDCS or sham stimulation. The primary focus is to assess changes in IL-6 levels, while secondary objectives include evaluating TNF-alpha levels and various symptom scales. The research aims to explore the immunomodulatory effects of tDCS and its potential to improve symptoms in chronic schizophrenia.
Who should consider this trial
Good fit: Ideal candidates are right-handed patients aged 18-60 with a clinical diagnosis of schizophrenia for more than 2 years and moderate to severe symptoms.
Not a fit: Patients with psychiatric emergencies, co-morbid neurological diseases, or contraindications to tDCS may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new treatment options that target inflammation and improve symptoms in patients with chronic schizophrenia.
How similar studies have performed: While the approach of using tDCS in schizophrenia is gaining interest, this specific application focusing on inflammatory biomarkers is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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. 4. 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.
Where this trial is running
Bhubaneswar, Odisha
- AIIMS Bhubaneswar — Bhubaneswar, Odisha, India (Recruiting)
Study contacts
- Study coordinator: Dr. Debadatta Mohapatra, MD
- Email: psych_debadatta@aiimsbhubaneswar.edu.in
- Phone: 9437658251
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.