Effect of tDCS on Inflammatory Biomarkers in Chronic Schizophrenia (NCT06349369) | Clinical Trial Compass
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Effect of tDCS on Inflammatory Biomarkers in Chronic Schizophrenia
India60 participantsStarted 2024-04-08
Plain-language 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.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in the IL-6 levels
Timeframe: 10 days
Trial details
NCT IDNCT06349369
SponsorAll India Institute of Medical Sciences, Bhubaneswar