Cognitive Effects of tDCS and tRNS in Schizophrenia

NCT ID: NCT06155786

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2024-07-22

Brief Summary

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The purpose of this study is to investigate the cognitive effects of different electrical stimulation modalities, such as transcranial direct and random-noise stimulation over the dorsolateral prefrontal cortex, in schizophrenia.

Detailed Description

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Conditions

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Schizophrenia Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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sham group

In sham group, placebo stimulation is generated by an electrical stimulator and is noninvasively delivered to the left and right dorsolateral prefrontal cortex through a pair of saline-soaked sponge electrodes (7×5 cm) for 30 minutes.

Group Type SHAM_COMPARATOR

transcranial direct current stimulation (tDCS) sham stimulator

Intervention Type DEVICE

Here a sham electrical current is applied directly between electrodes mounted on the head which can can de-or hyperpolarizes resting membrane potential and thereby modulate cortical excitability

tDCS group

In tDCS, direct electrical currents at the intensity of 2 mA are generated by an electrical stimulator and are noninvasively delivered to the left and right dorsolateral prefrontal cortex through a pair of saline-soaked sponge electrodes (7×5 cm) for 30 minutes.

Group Type ACTIVE_COMPARATOR

transcranial direct current stimulation (tDCS) active stimulator

Intervention Type DEVICE

In tDCS the electrical current is applied directly between electrodes mounted on the head which can can de-or hyperpolarizes resting membrane potential and thereby modulate cortical excitability

tRNS group

In tRNS, direct electrical currents at the intensity of 2 mA amplitude (offset at 1 mA) and frequency of 100-640 Hz are generated by an electrical stimulator and are noninvasively delivered to the left and right dorsolateral prefrontal cortex through a pair of saline-soaked sponge electrodes (7×5 cm) for 30 minutes.

Group Type ACTIVE_COMPARATOR

transcranial random noise stimulation (tRNS)

Intervention Type DEVICE

Here, an alternating electrical current is applied at a mix of frequencies it is called transcranial random noise stimulation (tRNS), which can be delivered in low (between 0.1-100 Hz) or high (between 101-640 Hz) frequency stimulation

Interventions

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transcranial direct current stimulation (tDCS) active stimulator

In tDCS the electrical current is applied directly between electrodes mounted on the head which can can de-or hyperpolarizes resting membrane potential and thereby modulate cortical excitability

Intervention Type DEVICE

transcranial random noise stimulation (tRNS)

Here, an alternating electrical current is applied at a mix of frequencies it is called transcranial random noise stimulation (tRNS), which can be delivered in low (between 0.1-100 Hz) or high (between 101-640 Hz) frequency stimulation

Intervention Type DEVICE

transcranial direct current stimulation (tDCS) sham stimulator

Here a sham electrical current is applied directly between electrodes mounted on the head which can can de-or hyperpolarizes resting membrane potential and thereby modulate cortical excitability

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of schizophrenia based on Diagnostic and Statistical Manual (DSM)5
* Being 18-50 years old (male and female)
* If female, negative urine pregnancy test
* feasibility for tDCS/tRNS interventions according to safety guidelines
* stable medication regime, especially for classical neuroleptics and all central nervous system activating medications, if taken, 4-6 weeks before the experiment
* fluency in the native language
* right-handed
* Required written informed consent signed by patients' guardian

Exclusion Criteria

* pregnancy
* alcohol or substance dependence
* comorbid bipolar disorder and mood disorder
* history of seizure
* history of neurological disorder
* history of head injury
* Presence of ferromagnetic objects in the body that are contraindicated for brain stimulation of the head (pacemakers or other implanted electrical devices, brain stimulators, some types of dental implants, aneurysm clips, metallic prostheses, permanent eyeliner, implanted delivery pump, or shrapnel fragments)
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Leibniz Research Centre for Working Environment and Human Factors

OTHER

Sponsor Role collaborator

Payame Noor University

UNKNOWN

Sponsor Role collaborator

The National Brain Mapping Laboratory (NBML)

OTHER

Sponsor Role lead

Responsible Party

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Mohammad Ali Salehinejad

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Payame Noor University, Tehran Branch

Tehran, , Iran

Site Status

Zanjan University

Zanjān, , Iran

Site Status

Countries

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Iran

Other Identifiers

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ifado-PNU

Identifier Type: -

Identifier Source: org_study_id