Transcranial Weak Current Stimulation Treatments for Working Memory Dysfunction in Schizophrenia

NCT04637724 | Completed

• 1 other identifier: 337-19
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

For the present study, Investigators will examine the efficacy of active prefrontal anodal tDCS versus placebo (sham) interventions to treat WM dysfunction in schizophrenia. Investigators selected the prefrontal stimulation modality that proved most effective in enhancing high-load WM performance in single dose stimulation in healthy participants . The study employs a multi-stimulation approach, with 2 sessions per day for 5 consecutive days in the active treatment group (n=15) compared to a group that receives only sham stimulation (n=15). This preliminary approach is based upon findings of a recent study applying cathodal tDCS stimulation over left temporoparietal cortex (with left prefrontal anodal stimulation) for the treatment of persistent auditory hallucinations in schizophrenia. In a a recent study clinical benefits were maintained for at least 3 months following stimulation. In the present study, in addition to clinical outcome, researchers will evaluate whether similar improvement can be obtained with WM, EEG activity, and functional outcome (e.g., discharged from hospitalization following significant improvement or remission).

Conditions

Schizophrenia; Schizo Affective Disorder

Keywords

Working memory; Schizophrenia symtom severity,; Prefrontal tDCS; Event related EEG

Outcome Measures

Primary Outcomes (3)

• change in Positivie and Negative Syndrome Scale (PANSS, minimum score = 30, maximum score = 350, higher score indicate incresed ilness severity, lower scores indicate lower ilness severity) scores from baseline to post-tDCS intervention

  change in total scores of the Positive and negative syndrome scale for Scizophrenia

  Immediately after 10-day tDCS-intervention

• change in working memory accuracy scores from baseline to post-tDCS intervention

  change in verbal working memory accuracy (scores range from 0 to 126 correct responses)

  Immediately after 10-day tDCS intervention

• change in working memory reaction times from baseline to post-tDCS intervention

  change in mean reaction times of correct rsponses (i.e., hits) (measures in millisecods range from 400 to 2000 msec)

  Immediately after 10-day tDCS intervention

Secondary Outcomes (3)

• change in Mismatch neagtivity (MMN) event related potentials from baseline to post-tDCS intervention

  Imediatly after after 10-dat tDCS intervention

• change from baseline to post-tDCS intervention in Induced EEG theta power folowing verbal command

  Immediatly after tDCS intervention

• change from baseline to post-tDCS intervention in Induced EEG alpha power folowing verbal command

  Immediatly after tDCS intervention

Study Arms (2)

active tDCS

EXPERIMENTAL

active prefrotal tDCS: 20 mins pes tDCS session, twice a day for 5 days. Total of 10 ative tDCS sessions.

Device: transcranial direct current stimulation (tDCS)

Sham tDCS

SHAM COMPARATOR

Sham prefrontal tDCS: sham stimulation 20 mins per session, twice a day for 5 days. Total of 10 sham stimulation sessions

Device: transcranial direct current stimulation (tDCS)

Interventions

transcranial direct current stimulation (tDCS) DEVICE

10 sessions of Anodal tDCS of the dorsolateral prefrontal cortex over a period of 5 consecutive days (two session a day). Each session includes the placement of two tDCS electrodes (anodal at left prefrontal area and cathodal above the vertex) and 20 mins of anodal prefrontal stimulation. The tDCS session is received two time a day with a 3-5 hours interveal betwen sessions.

Also known as: Prefrontal tDCS

Sham tDCS; active tDCS

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages 18-75
• Primary diagnosis of DSM-IV schizophrenia (including schizoaffective disorder)
• Right handed
• Under stable doses of antipsychotic medication for ≥4 weeks
• Normal vision by self report and physical exam
• Use of effective method of birth control for women of childbearing capacity
• Willing/capacity to provide informed consent
• Outpatients or volunteering inpatients or involuntary patients with consent of legal guardian.

You may not qualify if:

• Current or past history of substance dependence or abuse (excluding nicotine)
• Other current Axis I disorders
• History of seizure, epilepsy in self or first degree relatives, stoke, brain surgery, head injury, intracranial metal implants, known structural brain lesion, devices that may be affected by tDCS (pacemaker, medication pump, cochlear implant, implanted brain stimulator)
• Frequent and persistent migraines
• History of adverse reaction to neurostimulation
• Participation in study of investigational medication within 6 weeks
• Pregnancy
• Women who are breast-feeding
• Current significant laboratory abnormality

Sponsors & Collaborators

• Oded Meiron: lead

Study Sites (1)

Herzog Medical Center

Jerusalem, 91035, Israel

Location

Related Publications (3)

• Brunelin J, Mondino M, Gassab L, Haesebaert F, Gaha L, Suaud-Chagny MF, Saoud M, Mechri A, Poulet E. Examining transcranial direct-current stimulation (tDCS) as a treatment for hallucinations in schizophrenia. Am J Psychiatry. 2012 Jul;169(7):719-24. doi: 10.1176/appi.ajp.2012.11071091.

  PMID: 22581236 BACKGROUND

• Meiron O, Yaniv A, Rozenberg S, David J. Transcranial direct-current stimulation of the prefrontal cortex enhances working memory and suppresses pathological gamma power elevation in schizophrenia. Expert Rev Neurother. 2024 Feb;24(2):217-226. doi: 10.1080/14737175.2023.2294150. Epub 2024 Feb 6.

  PMID: 38084398 DERIVED

• Meiron O, David J, Yaniv A. Left prefrontal transcranial direct-current stimulation reduces symptom-severity and acutely enhances working memory in schizophrenia. Neurosci Lett. 2021 Jun 11;755:135912. doi: 10.1016/j.neulet.2021.135912. Epub 2021 Apr 21.

  PMID: 33894334 DERIVED

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

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

Study Officials

• Alex Borochov, MD

  Herzog Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Non-invasive Brain Stimulation Clinic

Model Details: Active tDCS versus Sham tDCS intervention

Study Record Dates

• First Submitted: November 11, 2020
• First Posted: November 20, 2020
• Study Start: November 29, 2019
• Primary Completion: August 30, 2023
• Study Completion: September 10, 2023
• Last Updated: September 25, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)