tDCS Combined With rTMS for Negative Symptoms of Schizophrenia

Summary

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.

Conditions

• Schizophrenia Negative Type

Interventions

DEVICE

tDCS active stimulation combined with rTMS sham stimulation

Active tDCS positive stimulation: left dorsolateral prefrontal cortex (DLPFC) or BeamF3 method; negative stimulation: right frontal, 2mA, 20 mins stimulation, 1 time/day, 5 consecutive days, weekend suspension, lasting 4 weeks, total 20 times. Sham stimulation rTMS: Parameters such as stimulation site, current intensity, and stimulation time are kept consistent, keeping the coil facing outward.

DEVICE

rTMS active stimulation combined with tDCS sham stimulation

Sham stimulation tDCS: Parameters such as stimulation site, current intensity, and stimulation time are kept consistent, keeping the switch off. Active rTMS: stimulation site: left dorsolateral prefrontal cortex (DLPFC); consisting of a total of 3000 pulses per session at 10Hz (4 seconds on and 16 seconds off) at 110% resting motion threshold (RMT), 40 pulses per string; total 75 strings; 1 time/day, 5 consecutive days, weekend suspension, total 20 times. Resting motor thresholds (RMT) were measured before the start of each day of treatment.

DEVICE

tDCS active stimulation combined with rTMS active stimulation

Active tDCS positive stimulation: left dorsolateral prefrontal cortex (DLPFC) or BeamF3 method; negative stimulation: right frontal, 2mA, 20 mins stimulation, 1 time/day, 5 consecutive days, weekend suspension, lasting 4 weeks, total 20 times. Active rTMS: stimulation site: left dorsolateral prefrontal cortex (DLPFC); consisting of a total of 3000 pulses per session at 10Hz (4 seconds on and 16 seconds off) at 110% resting motion threshold (RMT), 40 pulses per string; total 75 strings; 1 time/day, 5 consecutive days, weekend suspension, total 20 times. Resting motor thresholds (RMT) were measured before the start of each day of treatment.

DEVICE

tDCS sham stimulation combined with rTMS sham stimulation

Sham stimulation tDCS: Parameters such as stimulation site, current intensity, and stimulation time are kept consistent, keeping the switch off. Sham stimulation rTMS: Parameters such as stimulation site, current intensity, and stimulation time are kept consistent, keeping the coil facing outward.

Sponsors & Collaborators

• Chinese Academy of Sciences

  collaborator OTHER_GOV

• Tianjin Anding Hospital

  lead OTHER

Principal Investigators

• Shen Li, Doctor · Tianjin Anding Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-07-01

Primary Completion

2024-09-01

Completion

2024-12-30

Countries

• China

Study Locations