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

Primary Purpose

Schizophrenia, Cognitive Dysfunction

Status
Completed
Phase
Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
transcranial direct current stimulation (tDCS)
transcranial alternating current stimulation (tACS)
Sponsored by
The National Brain Mapping Laboratory (NBML)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Schizophrenia focused on measuring schizophrenia, tDCS, tACS, Cognition, dorsolateral prefrontal cortex

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Ardabil University of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

tDCS group

tACS group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.
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
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)

Secondary Outcome Measures

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).

Full Information

First Posted
March 26, 2022
Last Updated
August 4, 2022
Sponsor
The National Brain Mapping Laboratory (NBML)
Collaborators
Ardabil University of Medical Sciences, Leibniz-Institut für Arbeitsforschung
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1. Study Identification

Unique Protocol Identification Number
NCT05342727
Brief Title
Transcranial Direct and Alternating Stimulation of the Prefrontal Cortex for Cognitive Improvement in Schizophrenia
Official Title
The Impact of Transcranial Direct and Alternating Stimulation of the Prefrontal Cortex at Different Intensities and Frequencies on Cognition of Schizophrenic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
July 15, 2022 (Actual)
Study Completion Date
July 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The National Brain Mapping Laboratory (NBML)
Collaborators
Ardabil University of Medical Sciences, Leibniz-Institut für Arbeitsforschung

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Cognitive Dysfunction
Keywords
schizophrenia, tDCS, tACS, Cognition, dorsolateral prefrontal cortex

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Parallel group and each group with crossover design
Masking
ParticipantCare ProviderOutcomes 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.
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
tDCS group
Arm Type
Active Comparator
Arm Description
The tDCS arm receives two real (or active) stimulation at 2 mA and 3 mA intensities and one placebo electrical stimulation for 20 minutes.
Arm Title
tACS group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
transcranial direct current stimulation (tDCS)
Intervention Description
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
Intervention Name(s)
transcranial alternating current stimulation (tACS)
Intervention Description
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).
Primary Outcome Measure Information:
Title
Spatial Working Memory behavioral performance
Description
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.
Time Frame
During procedure (4 minutes)
Title
executive function behavioral performance
Description
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
Time Frame
During procedure (8-10 minutes)
Title
Emotional recognition behavioral performance
Description
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)
Time Frame
During procedure (60 minutes)
Secondary Outcome Measure Information:
Title
The Positive and Negative Affect Schedule (PANAS)
Description
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).
Time Frame
through study completion in each experimental session up to 1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Facility Information:
Facility Name
Ardabil University of Medical Sciences
City
Ardabil
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data will be available upon reasonable request from the PI after publication of results

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

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