Cognitive Effects of tDCS and tRNS in Schizophrenia

Not Applicable

Recruiting

• Conditions: Schizophrenia; Cognitive Impairment

• Registration Number: NCT06155786
• Lead Sponsor: The National Brain Mapping Laboratory (NBML)

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-01
• Primary Completion: 2023-11-01
• Study First Submitted: 2023-11-24
• Status Verified: 2023-12
• Study First Submitted QC: 2023-12-02
• Last Update Submitted: 2023-12-03
• Study First Posted: 2023-12-04
• Last Update Posted: 2023-12-08
• Study Completion: 2024-02-22

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Spatial Working Memory behavioral performance	During procedure (4 minutes)	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.
executive function behavioral performance	During procedure (8-10 minutes)	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
The Positive and Negative Affect Schedule (PANAS)	through study completion, an average of 3 weeks	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).

Trial Locations

Locations (2)

Payame Noor University, Tehran Branch; 🇮🇷 Tehran, Iran, Islamic Republic of

Zanjan University; 🇮🇷 Zanjān, Iran, Islamic Republic of