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

NCT ID: NCT05342727

Last Updated: 2022-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2022-07-31

Brief Summary

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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.

Detailed Description

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In this randomized, double-blind study, 50 patients diagnosed with schizophrenia are randomly assigned into two arms. The first group receives transcranial direct current stimulation (tDCS) at three intensities (2 mA, 3 mA, and sham) and the second group receives transcranial alternating current stimulation (tACS) at three different frequencies (8 Hz, 40 Hz, and sham) over the left dorsolateral prefrontal cortex for 20 min. There are at least 72 hours between stimulation sessions. The patients conduct three cognitive tasks from the CANTAB neuropsychological battery for schizophrenia during stimulation including a working memory task, a cognitive flexibility task, and an emotion recognition task. Mood stability is also evaluated before and after each stimulation session with the Positive and Negative Affect Scale (PANAS).

Conditions

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Schizophrenia Cognitive Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel group and each group with crossover design
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
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.

Study Groups

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tDCS group

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

Group Type ACTIVE_COMPARATOR

transcranial direct current stimulation (tDCS)

Intervention Type 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).

tACS group

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.

Group Type ACTIVE_COMPARATOR

transcranial alternating current stimulation (tACS)

Intervention Type 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).

Interventions

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transcranial direct current stimulation (tDCS)

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).

Intervention Type DEVICE

transcranial alternating current stimulation (tACS)

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).

Intervention Type DEVICE

Eligibility Criteria

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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 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
* 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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ardabil University of Medical Sciences

OTHER

Sponsor Role collaborator

Leibniz Research Centre for Working Environment and Human Factors

OTHER

Sponsor Role collaborator

The National Brain Mapping Laboratory (NBML)

OTHER

Sponsor Role lead

Responsible Party

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Mohammad Ali Salehinejad

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ardabil University of Medical Sciences

Ardabil, , Iran

Site Status

Countries

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Iran

Other Identifiers

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IR.ARUMS.REC.1400.043

Identifier Type: -

Identifier Source: org_study_id

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