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

Sponsor
The National Brain Mapping Laboratory (NBML) (Other)
Overall Status
Completed
CT.gov ID
NCT05342727
Collaborator
Ardabil University of Medical Sciences (Other), Leibniz-Institut für Arbeitsforschung (Other)
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: transcranial direct current stimulation (tDCS)
  • Device: transcranial alternating current stimulation (tACS)
Phase 1

Detailed Description

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).

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Parallel group and each group with crossover designParallel group and each group with crossover design
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description:
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.
Primary Purpose:
Basic Science
Official Title:
The Impact of Transcranial Direct and Alternating Stimulation of the Prefrontal Cortex at Different Intensities and Frequencies on Cognition of Schizophrenic Patients
Actual Study Start Date :
Apr 1, 2021
Actual Primary Completion Date :
Jul 15, 2022
Actual Study Completion Date :
Jul 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 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.

Device: 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).

Active Comparator: 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.

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).

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. Emotional recognition behavioral performance [During procedure (60 minutes)]

    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)

Secondary Outcome Measures

  1. The Positive and Negative Affect Schedule (PANAS) [through study completion in each experimental session up to 1 hour]

    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 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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ardabil University of Medical Sciences Ardabil Iran, Islamic Republic of

Sponsors and Collaborators

  • The National Brain Mapping Laboratory (NBML)
  • Ardabil University of Medical Sciences
  • Leibniz-Institut für Arbeitsforschung

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:
NCT05342727
Other Study ID Numbers:
  • IR.ARUMS.REC.1400.043
First Posted:
Apr 25, 2022
Last Update Posted:
Aug 8, 2022
Last Verified:
Aug 1, 2022
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
Keywords provided by Mohammad Ali Salehinejad, Principal Investigator, The National Brain Mapping Laboratory (NBML)
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 8, 2022