Effect of tDCS on Inflammatory Biomarkers in Chronic Schizophrenia

Chronic Schizophrenia Clinical Trial

— tDCS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06349369
• Other study ID #: PG Thesis/2023-24/105
• Status: Recruiting
• Phase: N/A
• Start date: April 8, 2024
• Est. completion date: April 9, 2026

Study information

• Verified date: April 2024
• Source: All India Institute of Medical Sciences, Bhubaneswar
• Contact: Dr. Debadatta Mohapatra, MD
• Phone: 9437658251
• Email: psych_debadatta[@]aiimsbhubaneswar.edu.in
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 9, 2026
• Est. primary completion date: December 9, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Schizophrenia
• Schizophrenia

Intervention

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.

Locations

Country	Name	City	State
India	AIIMS Bhubaneswar	Bhubaneswar	Odisha

Sponsors (1)

Lead Sponsor	Collaborator
All India Institute of Medical Sciences, Bhubaneswar

Country where clinical trial is conducted

India, 

References & Publications (14)

Agarwal SM, Shivakumar V, Bose A, Subramaniam A, Nawani H, Chhabra H, Kalmady SV, Narayanaswamy JC, Venkatasubramanian G. Transcranial direct current stimulation in schizophrenia. Clin Psychopharmacol Neurosci. 2013 Dec;11(3):118-25. doi: 10.9758/cpn.2013 — View Citation

Brunelin J, Mondino M, Gassab L, Haesebaert F, Gaha L, Suaud-Chagny MF, Saoud M, Mechri A, Poulet E. Examining transcranial direct-current stimulation (tDCS) as a treatment for hallucinations in schizophrenia. Am J Psychiatry. 2012 Jul;169(7):719-24. doi: — View Citation

Goerigk S, Cretaz E, Sampaio-Junior B, Vieira ELM, Gattaz W, Klein I, Lafer B, Teixeira AL, Carvalho AF, Lotufo PA, Bensenor IM, Buhner M, Padberg F, Brunoni AR. Effects of tDCS on neuroplasticity and inflammatory biomarkers in bipolar depression: Results — View Citation

Hafner H, an der Heiden W. Epidemiology of schizophrenia. Can J Psychiatry. 1997 Mar;42(2):139-51. doi: 10.1177/070674379704200204. — View Citation

Huarcaya-Victoria J, Villarreal-Rao B, Luna M, Rojas-Mendoza W, Alarcon-Ruiz CA, Villarreal-Zegarra D, Vilela-Estrada AL, Ramirez S. Factors Associated with Mental Health Outcomes in Hospital Workers during the COVID-19 Pandemic: A Mixed-Methods Study. In — View Citation

Muller N, Weidinger E, Leitner B, Schwarz MJ. The role of inflammation in schizophrenia. Front Neurosci. 2015 Oct 21;9:372. doi: 10.3389/fnins.2015.00372. eCollection 2015. — View Citation

Palm U, Keeser D, Hasan A, Kupka MJ, Blautzik J, Sarubin N, Kaymakanova F, Unger I, Falkai P, Meindl T, Ertl-Wagner B, Padberg F. Prefrontal Transcranial Direct Current Stimulation for Treatment of Schizophrenia With Predominant Negative Symptoms: A Doubl — View Citation

Schennach R, Riedel M, Obermeier M, Spellmann I, Musil R, Jager M, Schmauss M, Laux G, Pfeiffer H, Naber D, Schmidt LG, Gaebel W, Klosterkotter J, Heuser I, Maier W, Lemke MR, Ruther E, Klingberg S, Gastpar M, Moller HJ. What are residual symptoms in schi — View Citation

Siskind D, Siskind V, Kisely S. Clozapine Response Rates among People with Treatment-Resistant Schizophrenia: Data from a Systematic Review and Meta-Analysis. Can J Psychiatry. 2017 Nov;62(11):772-777. doi: 10.1177/0706743717718167. Epub 2017 Jun 28. — View Citation

Thair H, Holloway AL, Newport R, Smith AD. Transcranial Direct Current Stimulation (tDCS): A Beginner's Guide for Design and Implementation. Front Neurosci. 2017 Nov 22;11:641. doi: 10.3389/fnins.2017.00641. eCollection 2017. — View Citation

Valiengo LDCL, Goerigk S, Gordon PC, Padberg F, Serpa MH, Koebe S, Santos LAD, Lovera RAM, Carvalho JB, van de Bilt M, Lacerda ALT, Elkis H, Gattaz WF, Brunoni AR. Efficacy and Safety of Transcranial Direct Current Stimulation for Treating Negative Sympto — View Citation

Vaseghi B, Zoghi M, Jaberzadeh S. A meta-analysis of site-specific effects of cathodal transcranial direct current stimulation on sensory perception and pain. PLoS One. 2015 May 15;10(5):e0123873. doi: 10.1371/journal.pone.0123873. eCollection 2015. — View Citation

Woods AJ, Antal A, Bikson M, Boggio PS, Brunoni AR, Celnik P, Cohen LG, Fregni F, Herrmann CS, Kappenman ES, Knotkova H, Liebetanz D, Miniussi C, Miranda PC, Paulus W, Priori A, Reato D, Stagg C, Wenderoth N, Nitsche MA. A technical guide to tDCS, and rel — View Citation

Xu H, Zhou Y, Wang J, Liang Z, Wang Y, Wu W, Liu Y, Liu X, Zhang X, Huo L. Effect of HD-tDCS on white matter integrity and associated cognitive function in chronic schizophrenia: A double-blind, sham-controlled randomized trial. Psychiatry Res. 2023 Jun;3 — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the IL-6 levels		10 days
Secondary	Change in the TNF alpha levels.		10 days
Secondary	Change in the Positive and Negative syndrome Scale	score 1- absent symptoms Score 7- extreme symptoms	5 days and 10 days
Secondary	Change in the Auditory hallucination rating scale	score 0- No Auditory hallucination Score 9- Severe Auditory hallucination	5 days and 10 days
Secondary	Change in the Clinical global impression- Schizophrenia scale	score 0- not assessed score 7- extremely ill patients	5 days and 10 days
Secondary	Change in the Global Assessment of Functioning scale	score 0- inadequate information score 100- No symptoms	5 days and 10 days
Secondary	To compare the adverse events reported in both control and intervention groups.		5 days and 10 days