NCT05200962

Brief Summary

The purpose of this study is to investigate the mechanism of action of transcranial electrical brain stimulation over the dorsolateral prefrontal cortex for cognitive impairment in schizophrenia. To do so the effect of a 3-mA stimulation protocol on neurocognitive functions will be investigated using behavioral performance and fMRI.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1 schizophrenia

Timeline
Completed

Started Feb 2022

Longer than P75 for phase_1 schizophrenia

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

December 22, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 21, 2022

Completed
11 days until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

2.3 years

First QC Date

December 22, 2021

Last Update Submit

November 9, 2023

Conditions

SchizophreniaCognitive Impairment

Keywords

Schizophreniacognitive impairmentTranscranial direct current stimulationfMRI

Outcome Measures

Primary Outcomes (2)

  • Working memory behavioral performance

    A computerized version of 3- back letter task, optimized for administration in a functional MRI environment will be employed during the experiment

    up to 24 hours after the intervention

  • Modifications to blood-oxygen-level-dependent (BOLD) signal

    Changes to blood-oxygen-level-dependent (BOLD) signal (arbitrary units) of brain areas that are implicated in cognitive impairment and pathophysiology of schizophrenia during the working memory task, as measured by fMRI following the intervention between the active and sham groups.

    up to 1 hour

Study Arms (2)

Active tDCS group

EXPERIMENTAL

The experimental arm receives real (or active) electrical stimulation for 20 minutes

Device: transcranial direct current stimulation

sham tDCS group

SHAM COMPARATOR

The sham arm receives sham (or no real) intervention in which stimulation lasts for 30 seconds and ends afterward.

Device: transcranial direct current stimulation

Interventions

transcranial direct current stimulationDEVICE

In tDCS, direct electrical currents are generated by an electrical stimulator and are noninvasively delivered to the scalp through a pair of saline-soaked sponge electrodes (7Ă—5 cm).

Also known as: tDCS, tES
Active tDCS groupsham tDCS group

Eligibility Criteria

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

You may qualify if:

  • men or women (18-50 yrs old) with a DSM 5 SCZ diagnosis,
  • If female, negative urine pregnancy test
  • significant cognitive impairment (1 SD below the norm on the working memory/executive functioning task performance)
  • feasibility for tDCS interventions according to safety guidelines
  • stable medication regime especially the classical neuroleptics and all CNS-activating medications, if taken, 4-6 weeks before the experiment
  • fluency in the native language
  • right-handed
  • ability to provide informed consent.

You may not qualify if:

  • pregnancy
  • alcohol or substance dependence
  • history of seizure
  • history of neurological disorder
  • history of head injury
  • Presence of ferromagnetic objects in the body that are contraindicated for MRI 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) or fear of enclosed spaces). Eligibility will be determined by the "MRI Safety Screening Questionnaire" and verified, if necessary, by a radiology consultant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The National Brain Mapping Laboratory (NBML)

Tehran, Iran

Location

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
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 22, 2021

First Posted

January 21, 2022

Study Start

February 1, 2022

Primary Completion

May 30, 2024

Study Completion

August 1, 2024

Last Updated

November 13, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

IR(1)