Transcranial Direct and Alternating Stimulation of the Prefrontal Cortex for Cognitive Improvement in Schizophrenia

NCT05342727 | Completed Phase 1 DMC

• 1 other identifier: IR.ARUMS.REC.1400.043
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate different stimulation intensities and frequencies of transcranial direct and alternating current stimulation over the dorsolateral prefrontal cortex for cognitive improvement in schizophrenia.

Conditions

Schizophrenia; Cognitive Dysfunction

Keywords

schizophrenia; tDCS; tACS; Cognition; dorsolateral prefrontal cortex

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)

• Emotional recognition behavioral performance

  Computer-morphed images derived from the facial features of real individuals, each showing a specific emotion, are displayed on the screen, one at a time. Each face is displayed for 200 milliseconds and then immediately covered up to prevent residual processing of the image. The participant must select which emotion the face displayed from 6 options (sadness, happiness, fear, anger, disgust or surprise)

  During procedure (60 minutes)

Secondary Outcomes (1)

• The Positive and Negative Affect Schedule (PANAS)

  through study completion in each experimental session up to 1 hour

Study Arms (2)

tDCS group

ACTIVE COMPARATOR

The tDCS arm receives two real (or active) stimulation at 2 mA and 3 mA intensities and one placebo electrical stimulation for 20 minutes.

Device: transcranial direct current stimulation (tDCS)

tACS group

ACTIVE COMPARATOR

The tACS arm receives two real (or active) stimulation at 8 Hz and 40 Hz frequencies and one placebo alternating electrical stimulation for 20 minutes.

Device: transcranial alternating current stimulation (tACS)

Interventions

transcranial direct current stimulation (tDCS) DEVICE

In tDCS, direct electrical currents at the intensity of interest (2 mA for example) are generated by an electrical stimulator and are noninvasively delivered to the scalp through a pair of saline-soaked sponge electrodes (7×5 cm).

tDCS group

transcranial alternating current stimulation (tACS) DEVICE

In tACS, alternating electrical currents at the frequency of interest (8 Hz for example) are generated by an electrical stimulator and are noninvasively delivered to the scalp through a pair of saline-soaked sponge electrodes (7×5 cm).

tACS group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis of schizophrenia based on DSM V,
• Being 18-50 years old (male and female)
• If female, negative urine pregnancy test
• 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
• Required written informed consent signed by patients' guardian

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 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) or fear of enclosed spaces).

Sponsors & Collaborators

• The National Brain Mapping Laboratory (NBML): lead
• Ardabil University of Medical Sciences: collaborator
• Leibniz Research Centre for Working Environment and Human Factors: collaborator

Study Sites (1)

Ardabil University of Medical Sciences

Ardabil, Iran

Location

MeSH Terms

Conditions

Schizophrenia; Cognitive Dysfunction

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Cognition Disorders; Neurocognitive Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Allocation Concealment is used to perform a random sequence on study participants. Also, non-transparent envelopes sealed with random sequences will be used, in a way that each random sequence is recorded on a card, and the cards are placed in the envelope in order. In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface. Finally, the lids of the envelopes are glued and placed inside a box. At the beginning of the registration, according to the order of entry of the eligible participants, one of the envelopes will be opened in order and the assigned group of the participant will be revealed.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Parallel group and each group with crossover design

Study Record Dates

• First Submitted: March 26, 2022
• First Posted: April 25, 2022
• Study Start: April 1, 2021
• Primary Completion: July 15, 2022
• Study Completion: July 31, 2022
• Last Updated: August 8, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)