Transcranial Direct Current Stimulation (tDCS) as a Treatment for Cognitive Deficits in Schizophrenic

January 15, 2019 updated by: Shanghai Mental Health Center

Research on Transcranial Direct Current Stimulation (tDCS) as a Treatment for Cognitive Deficits in Schizophrenic

This trial attempts to evaluate the effects of intensive transcranial direct-current stimulation (tDCS) on improving cognition in schizophrenia patients and changes in resting state brain network connectivity, especially increasing connectivity in the tasks related network, and increasing activation the DLPFC in a working memory task. Half of the participants will be randomized to tDCS group, while the other half will be randomized to receive sham tDCS.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Schizophrenia patients (SZ) show profound and persistent cognitive deficits in attention, executive processing, and verbal and visuospatial memory, which persist even after psychotic symptoms are ameliorated. Cognitive deficits may be more important in preventing functional, occupational, and social recovery in SZ than other symptom domains and are not effectively treated by current pharmacological approaches. Transcranial direct-current stimulation (tDCS) is less expensive than other modalities (e.g. repetitive transcranial magnetic stimulation; rTMS), easily available, and has a good safety profile in healthy controls (HC) and SZ. However, these prior studies did not make use of a validated measure such as the MATRICS consensus battery (MCCB), which is now established as the standard for assessing cognitive improvement in SZ. Despite these promising preliminary results, this effect of tDCS in SZ needs to be confirmed and the underlying biological mechanism elucidated. Therefore, the investigators employed MCCB to evaluate the effects on improving cognition and functional MRI to explore the underlying mechanism.

Half of the participants will be randomized to tDCS group, while the other half will be randomized to receive sham tDCS. Active vs. sham treatment will be randomly using computer generated lists. Subjects and researcher-administrators of tDCS and testers or evaluators will be blind to treatment.The main cognitive outcome measure, the MCCB, will be administered at baseline and 1 day after the last tDCS session.Participants will be scanned once prior to tDCS sessions, and within one day after the 10th tDCS sessions using our Siemens 3T Verio MRI scanner.

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200030
        • Shanghai Mental Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects who have cognitive deficits as indicated by a score of < 85 on RBANS, and meet criteria for DSM-5 diagnosis of chronic SZ, schizoaffective disorder (SA), or schizophreniform disorder (SZF), and who are stably treated with antipsychotic medications and are not in acute exacerbation of illness symptoms.

Exclusion Criteria:

  • Patients with risk factors for an MRI scan, seizure disorder, and for women of childbearing age who are pregnant or regularly engaging in sexual activity and not regularly using an acceptable birth control method (systemic or double-barrier).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: tDCS group
The active tDCS group will be stimulated with transcranial Direct Current Stimulation (tDCS).
Device: tDCS
Electrodes for tDCS will have the anode placed over the left DLPFC (F3) and the cathode over the contralateral (right) supraorbital ridge. The exact location of electrodes will be determined by the 10/20 EEG method with EEG cap. Subjects will have tDCS sessions on consecutive days (weekends and holidays excluded). The tDCS group will have 10 active or sham tDCS sessions. The active group will be stimulated with a 2 mA current for 20 minutes.
SHAM_COMPARATOR: Sham tDCS group
The sham tDCS group will have stimulation with sham transcranial Direct Current Stimulation (tDCS).
Device: Sham tDCS
Electrodes for tDCS will have the anode placed over the left DLPFC (F3) and the cathode over the contralateral (right) supraorbital ridge. The exact location of electrodes will be determined by the 10/20 EEG method with EEG cap. Subjects will have tDCS sessions on consecutive days (weekends and holidays excluded). The sham tDCS group will have 10 active or sham tDCS sessions. The sham group will have stimulation lasting only 40 seconds though the electrodes will remain in place for 20 min.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The MATRICS Consensus Cognitive Battery (MCCB)
Time Frame: Change from Baseline MCCB through study completion, an average of 15 days
Change from Baseline MCCB through study completion, an average of 15 days
Neuroimage changes in Magnetic Resonance Imaging (MRI)
Time Frame: Change from Baseline MCCB through study completion, an average of 15 days
Including T1, resting state functional MRI, task based functional MRI and Diffusion Tensor Imaging(DTI)
Change from Baseline MCCB through study completion, an average of 15 days

Secondary Outcome Measures

Outcome Measure
Time Frame
The CogState: Working memory and attention
Time Frame: through study completion, an average of 15 days
through study completion, an average of 15 days
The Positive and Negative Syndrome Scale (PANSS)
Time Frame: Change from Baseline MCCB through study completion, an average of 15 days
Change from Baseline MCCB through study completion, an average of 15 days
Side-effects of tDCS
Time Frame: through study completion, an average of 15 days
through study completion, an average of 15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Mental Health Center

Collaborators

Nathan Kline Institute for Psychiatric Research

Investigators

  • Principal Investigator: Chunbo Li, Ph.D., Shanghai Mental Health Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2015

Primary Completion (ACTUAL)

September 1, 2017

Study Completion (ACTUAL)

October 1, 2017

Study Registration Dates

First Submitted

January 15, 2016

First Submitted That Met QC Criteria

April 19, 2016

First Posted (ESTIMATE)

April 22, 2016

Study Record Updates

Last Update Posted (ACTUAL)

January 17, 2019

Last Update Submitted That Met QC Criteria

January 15, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-09

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan to share IPD data

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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