NCT06155786

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable schizophrenia

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable schizophrenia

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

November 24, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 4, 2023

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 22, 2024

Completed
Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

10 months

First QC Date

November 24, 2023

Last Update Submit

March 15, 2026

Conditions

Cognitive ImpairmentSchizophrenia

Outcome Measures

Primary Outcomes (3)

  • Spatial Working Memory behavioral performance

    The test begins with a number of coloured squares (boxes) shown on the screen. The aim of this test is that by selecting the boxes and using a process of elimination, the participant should find one yellow 'token' in each of a number of boxes and use them to fill up an empty column on the right-hand side of the screen.

    During procedure (4 minutes)

  • executive function behavioral performance

    The participant is shown two displays containing three coloured balls. The test administrator first demonstrates to the participant how to move the balls in the lower display to copy the pattern in the upper display and completes one demonstration problem, where the solution requires one move. The participant must then complete three further problems, one each requiring two moves, three moves, and four moves. Next, the participant is shown further problems and must work out in their head how many moves the solutions require and then select the appropriate box at the bottom of the screen to indicate their response

    During procedure (8-10 minutes)

  • The Positive and Negative Affect Schedule (PANAS)

    The Positive and Negative Affect Schedule (PANAS) is a self-report questionnaire that consists of two 10-item scales to measure both positive and negative affect. Each item is rated on a 5-point scale of 1 (not at all) to 5 (very much).

    through study completion, an average of 3 weeks

Study Arms (3)

tDCS group

ACTIVE COMPARATOR

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.

Device: transcranial direct current stimulation (tDCS) active stimulator

tRNS group

ACTIVE COMPARATOR

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.

Device: transcranial random noise stimulation (tRNS)

sham group

SHAM COMPARATOR

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.

Device: transcranial direct current stimulation (tDCS) sham stimulator

Interventions

transcranial direct current stimulation (tDCS) active stimulatorDEVICE

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

tDCS group
transcranial random noise stimulation (tRNS)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

tRNS group
transcranial direct current stimulation (tDCS) sham stimulatorDEVICE

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

sham group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Payame Noor University, Tehran Branch

Tehran, Iran

Location

Zanjan University

Zanjān, Iran

Location

Related Publications (1)

  • Jafari E, Moghadamzadeh A, Vaziri Z, Atadokht A, Fathi Jouzdani A, Cohen Kadosh R, Nitsche MA, Blumberger DM, Salehinejad MA. Cognitive and emotional effects of bilateral prefrontal anodal tDCS and high-frequency tRNS in schizophrenia: a randomized sham-controlled study. Schizophrenia (Heidelb). 2026 Jan 13;12(1):28. doi: 10.1038/s41537-025-00720-z.

    PMID: 41530140RESULT

Related Links

MeSH Terms

Conditions

SchizophreniaCognitive Dysfunction

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersCognition DisordersNeurocognitive Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 24, 2023

First Posted

December 4, 2023

Study Start

January 1, 2023

Primary Completion

November 1, 2023

Study Completion

July 22, 2024

Last Updated

March 18, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

IR(2)