Effect of tDCS on Inflammatory Biomarkers in Chronic Schizophrenia

All India Institute of Medical Sciences, Bhubaneswar

Status: Enrolling

Conditions: Chronic Schizophrenia

Treatments: Device: transcranial direct current stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06349369

PG Thesis/2023-24/105

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Treatment group

Experimental group

Description:

the cathode will be located over a point midway between T3 and P3 (left temporo-parietal junction, assumed to correspond to a region including BA 22, 39, 40, 41, and 42, depending on the patient) and the anode will be placed with the middle of the electrode over a point midway between F3 and FP1 (left prefrontal cortex: dorsolateral prefrontal cortex, assumed to correspond to a region including Brodmann's areas \[BA\] 8, 9, 10, and 46, depending on the patient).The transcranial brain stimulation will be given 2 sessions per day for 10 days, in which 20 minutes of stimulation with an inter-session interval of 3 hours.

Treatment:

Device: transcranial direct current stimulation

Sham control group

Sham Comparator group

Description:

To Maximize the stimulatory effects 1mA current will be applied for the first 30 seconds, to provide the initial sensation of real stimulation and then the current will be stopped, thus minimizing the stimulatory effects.

Treatment:

Device: transcranial direct current stimulation