Clinical trial NCT06349369: Effect of tDCS on Inflammatory Biomarkers in Chronic Schizophrenia
Official title: Effect of Transcranial Direct Current Stimulation (tDCS) on Inflammatory Biomarkers in Chronic Schizophrenia: A Randomised Double-Blind Controlled Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Schizophrenia
Lead sponsor: All India Institute of Medical Sciences, Bhubaneswar
Sponsor class: OTHER
First posted: 2024-04-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in the IL-6 levels
timeFrame: 10 days
Secondary outcomes:
measure: Change in the TNF alpha levels.
timeFrame: 10 days
measure: Change in the Positive and Negative syndrome Scale
timeFrame: 5 days and 10 days
measure: Change in the Auditory hallucination rating scale
timeFrame: 5 days and 10 days
measure: Change in the Clinical global impression- Schizophrenia scale
timeFrame: 5 days and 10 days
measure: Change in the Global Assessment of Functioning scale
timeFrame: 5 days and 10 days
measure: To compare the adverse events reported in both control and intervention groups.
timeFrame: 5 days and 10 days
Other outcomes:
Locations:
city: Bhubaneswar
country: India
facility: AIIMS Bhubaneswar
state: Odisha
Study officials:
References:
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 related non-invasive brain stimulation tools. Clin Neurophysiol. 2016 Feb;127(2):1031-1048. doi: 10.1016/j.clinph.2015.11.012. Epub 2015 Nov 22.
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.
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;324:115183. doi: 10.1016/j.psychres.2023.115183. Epub 2023 Mar 27.
citation: Hafner H, an der Heiden W. Epidemiology of schizophrenia. Can J Psychiatry. 1997 Mar;42(2):139-51. doi: 10.1177/070674379704200204.
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 schizophrenia spectrum disorder? Clinical description and 1-year persistence within a naturalistic trial. Eur Arch Psychiatry Clin Neurosci. 2015 Mar;265(2):107-16. doi: 10.1007/s00406-014-0528-2. Epub 2014 Sep 27.
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 Double-Blind, Sham-Controlled Proof-of-Concept Study. Schizophr Bull. 2016 Sep;42(5):1253-61. doi: 10.1093/schbul/sbw041. Epub 2016 Apr 20.
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.
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.
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. Int J Environ Res Public Health. 2022 Apr 28;19(9):5346. doi: 10.3390/ijerph19095346.
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.
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: 10.1176/appi.ajp.2012.11071091.
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 Symptoms in Schizophrenia: A Randomized Clinical Trial. JAMA Psychiatry. 2020 Feb 1;77(2):121-129. doi: 10.1001/jamapsychiatry.2019.3199.
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 from a sham-controlled study. Prog Neuropsychopharmacol Biol Psychiatry. 2021 Mar 8;105:110119. doi: 10.1016/j.pnpbp.2020.110119. Epub 2020 Oct 4.
citation: 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.2013.11.3.118. Epub 2013 Dec 24.