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

NCT02748083 | Completed DMC

• 1 other identifier: 2015-09
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Schizophrenia

Keywords

tDCS; schizophrenia; cognition; fMRI

Outcome Measures

Primary Outcomes (2)

• The MATRICS Consensus Cognitive Battery (MCCB)

  Change from Baseline MCCB through study completion, an average of 15 days

• Neuroimage changes in Magnetic Resonance Imaging (MRI)

  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 Outcomes (3)

• The CogState: Working memory and attention

  through study completion, an average of 15 days

• The Positive and Negative Syndrome Scale (PANSS)

  Change from Baseline MCCB through study completion, an average of 15 days

• Side-effects of tDCS

  through study completion, an average of 15 days

Study Arms (2)

tDCS group

ACTIVE COMPARATOR

The active tDCS group will be stimulated with transcranial Direct Current Stimulation (tDCS).

Device: tDCS

Sham tDCS group

SHAM COMPARATOR

The sham tDCS group will have stimulation with sham transcranial Direct Current Stimulation (tDCS).

Device: Sham tDCS

Interventions

tDCS DEVICE

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.

tDCS group

Sham tDCS DEVICE

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.

Sham tDCS group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Shanghai Mental Health Center: lead
• Nathan Kline Institute for Psychiatric Research: collaborator

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

Location

Related Publications (1)

• Smith RC, Md WL, Wang Y, Jiang J, Wang J, Szabo V, Faull R, Jin H, Davis JM, Li C. Effects of transcranial direct current stimulation on cognition and symptoms in Chinese patients with schizophrenia✰. Psychiatry Res. 2020 Feb;284:112617. doi: 10.1016/j.psychres.2019.112617. Epub 2019 Nov 2.

  PMID: 31806403 DERIVED

MeSH Terms

Conditions

Schizophrenia

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

• Chunbo Li, Ph.D.

  Shanghai Mental Health 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

Study Record Dates

• First Submitted: January 15, 2016
• First Posted: April 22, 2016
• Study Start: December 1, 2015
• Primary Completion: September 1, 2017
• Study Completion: October 1, 2017
• Last Updated: January 17, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)