Effect of tDCS on Inflammatory Biomarkers in Chronic Schizophrenia (tDCS)

April 24, 2024 updated by: Dr. Debadatta Mohapatra, All India Institute of Medical Sciences, Bhubaneswar

Effect of Transcranial Direct Current Stimulation (tDCS) on Inflammatory Biomarkers in Chronic Schizophrenia: A Randomised Double-Blind Controlled Trial.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • India
    • Odisha
      • Bhubaneswar, Odisha, India, 751019
        • Recruiting
        • AIIMS Bhubaneswar
        • Contact:
          • Ashutosh Biswas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment group
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.
Device: transcranial 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.
Sham Comparator: Sham control group
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.
Device: transcranial 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in the IL-6 levels
Time Frame: 10 days
10 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

All India Institute of Medical Sciences, Bhubaneswar

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 8, 2024

Primary Completion (Estimated)

December 9, 2025

Study Completion (Estimated)

April 9, 2026

Study Registration Dates

First Submitted

April 1, 2024

First Submitted That Met QC Criteria

April 1, 2024

First Posted (Actual)

April 5, 2024

Study Record Updates

Last Update Posted (Actual)

April 25, 2024

Last Update Submitted That Met QC Criteria

April 24, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PG Thesis/2023-24/105

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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