Cognitive Effects of tDCS and tRNS in Schizophrenia

Sponsor
The National Brain Mapping Laboratory (NBML) (Other)
Overall Status
Recruiting
CT.gov ID
NCT06155786
Collaborator
Leibniz-Institut für Arbeitsforschung (Other), Payame Noor University (Other)
36
1
3
13.7
2.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: transcranial direct current stimulation (tDCS)
  • Device: transcranial random noise stimulation (tRNS)
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Cognitive Effects of Transcranial Direct Current Stimulation (tDCS) and Transcranial Random Noise Stimulation (tRNS) in Schizophrenia: A Random, Crossover Study
Actual Study Start Date :
Jan 1, 2023
Actual Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Feb 22, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 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.

Device: transcranial direct current stimulation (tDCS)
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

Active Comparator: 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.

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

Sham Comparator: 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.

Device: transcranial direct current stimulation (tDCS)
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

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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

  3. 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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Diagnosis of schizophrenia based on DSM V,

  • 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 the classical neuroleptics and all CNS-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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Clinics related to Payame Noor University Tehran Iran, Islamic Republic of

Sponsors and Collaborators

  • The National Brain Mapping Laboratory (NBML)
  • Leibniz-Institut für Arbeitsforschung
  • Payame Noor University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mohammad Ali Salehinejad, Principal Investigator, The National Brain Mapping Laboratory (NBML)
ClinicalTrials.gov Identifier:
NCT06155786
Other Study ID Numbers:
  • ifado-PNU
First Posted:
Dec 4, 2023
Last Update Posted:
Dec 4, 2023
Last Verified:
Dec 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 4, 2023