Cognitive Effects of tDCS and tRNS in Schizophrenia

Schizophrenia Clinical Trial

Official title:

Cognitive Effects of Transcranial Direct Current Stimulation (tDCS) and Transcranial Random Noise Stimulation (tRNS) in Schizophrenia: A Random, Crossover Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06155786
• Other study ID #: ifado-PNU
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: February 22, 2024

Study information

• Verified date: December 2023
• Source: The National Brain Mapping Laboratory (NBML)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: February 22, 2024
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cognitive Impairment
• Schizophrenia

Intervention

Device:
• 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
• 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
• 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

Locations

Country	Name	City	State
Iran, Islamic Republic of	Payame Noor University, Tehran Branch	Tehran
Iran, Islamic Republic of	Zanjan University	Zanjan

Sponsors (3)

Lead Sponsor	Collaborator
The National Brain Mapping Laboratory (NBML)	Leibniz-Institut für Arbeitsforschung, Payame Noor University

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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