Chronic Schizophrenia
Conditions
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.
Interventions
DEVICEtranscranial direct current stimulation
tDCS is a non-invasive neuromodulation technique that has gained attention for its potential to influence neural activity and address cognitive and functional deficits in individuals with schizophrenia. It involves applying a weak direct electrical current to the scalp, which can increase or decrease the excitability of underlying brain regions.
Sponsors
All India Institute of Medical Sciences, Bhubaneswar
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the IL-6 levels | 10 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| Change in the Positive and Negative syndrome Scale | 5 days and 10 days | score 1- absent symptoms Score 7- extreme symptoms |
Countries
India
Contacts
Primary ContactDr. Debadatta Mohapatra, MD
Outcome results
None listed