NCT05695144: NIBSNeS

tDCS Combined With rTMS for Negative Symptoms of Schizophrenia

Status unknown NA Last updated 23 January 2023

What this trial tests

NA trial testing tDCS active stimulation combined with rTMS sham stimulation in Schizophrenia Negative Type in 120 participants. Status unknown.

Timeline

1 July 2022

Primary endpoint
1 September 2024

30 December 2024

Quick facts

Lead sponsor	Tianjin Anding Hospital
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	120
Start date	1 July 2022
Primary completion	1 September 2024
Estimated completion	30 December 2024
Sites	1 location across China

Drugs / interventions tested

• tDCS active stimulation combined with rTMS sham stimulation
• rTMS active stimulation combined with tDCS sham stimulation
• tDCS active stimulation combined with rTMS active stimulation
• tDCS sham stimulation combined with rTMS sham stimulation

Conditions studied

• Schizophrenia Negative Type — all drugs for Schizophrenia Negative Type →

Sponsor

Tianjin Anding Hospital

Who can join

Adults 18 to 60, any sex, with Schizophrenia Negative Type. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Despite major advances in the field of psychopharmacology in recent years, the majority of treated schizophrenia patients retain disabling symptoms, most commonly a variety of negative symptoms. Currently, clinical treatment of schizophrenia remains dominated by pharmacological control. The current use of antipsychotic medications is effective in controlling the positive symptoms of schizophrenia, but has little effect on the negative symptoms. Neuroimaging and neurophysiological studies have shown that negative symptoms are associated with abnormal brain activity in the combined right and left dorsolateral prefrontal and temporoparietal joint regions, and that physical therapy techniques can modulate cortical activity. Therefore, this study aims to investigate the efficacy of transcranial direct current stimulation(tDCS) combined with repetitive transcranial magnetic stimulation(rTMS) on negative symptoms in patients with schizophrenia and to explore possible mechanisms.

The double-blind randomized placebo-controlled study comparing active tDCS stimulation combined with active rTMS stimulation, active rTMS stimulation combined with sham tDCS stimulation, and active tDCS stimulation combined with sham rTMS stimulation to sham tDCS stimulation combined with sham rTMS stimulation at 4 weeks of treatment and 2 weeks of follow-up in patients with predominantly negative symptoms with schizophrenia was studied for efficacy. In addition to the primary observation of changes in the Negative Symptom Assessment Scale (SANS), secondary outcomes include changes in Positive and Negative symptom scale (PANSS) total and negative total scores, changes in the MATRICS Consensus Cognitive Battery (MCCB), changes in local brain activity (functional magnetic resonance imaging, fMRI), white matter integrity (diffusion tensor imaging, DTI), changes in laboratory examination indices changes and changes in psycho-behavioral and EEG index.

This is the first clinical trial combining tDCS with rTMS for the treatment of schizophrenia patients with predominantly negative symptoms. This study will provide solid evidence for the combination of tDCS with rTMS for the treatment of negative symptoms in schizophrenia. This study will also help to further explore the mechanisms of tDCS combined with rTMS for the treatment of negative symptoms in schizophrenia in terms of imaging and behavior.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.