NCT03756610

Brief Summary

This trial attempts to investigate whether 10 sessions of tACS improves cognitive function, especially which domains of cognitive function are most improved and to investigate whether 10 sessions of tACS affecting brain activation during a working memory task and changes patterns of brain connectivity networks.Subjects will be divided into 2 groups 2:1, active and sham tACS. 50 subjects will be in the active group, and 25 subjects in the sham group (specific numbers to be decided on later).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable schizophrenia

Timeline
Completed

Started Nov 2018

Shorter than P25 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

November 28, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

November 28, 2018

Status Verified

October 1, 2018

Enrollment Period

1.1 years

First QC Date

October 27, 2018

Last Update Submit

November 26, 2018

Conditions

Schizophrenia

Keywords

tACSschizophreniacognitionfMRI

Outcome Measures

Primary Outcomes (3)

  • changes in The MATRICS Consensus Cognitive Battery (MCCB)

    Change from Baseline MCCB at 2 weeks.

  • changes in 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 at 2 weeks.

  • changes in Gamma oscillation intensity ( 40-80 Hz) over the left and right frontal lobe

    measured by electroencephalogram (EEG)

    Change from Baseline at 2 weeks.

Secondary Outcomes (6)

  • N-back task

    At baseline,1-week, 2-week, 4-week, and 8-week follow-up.

  • The Paced Auditory Serial Addition Task (PASAT)

    At baseline,2-week, 4-week, and 8-week follow-up.

  • The Positive and Negative Syndrome Scale (PANSS)

    At baseline,2-week, 4-week, and 8-week follow-up.

  • The USCD Performance- Based Skills Assessment Battery (UPSA)

    At baseline,2-week, 4-week, and 8-week follow-up.

  • Side-effects of tACS

    At each stimulation session,up to 2 weeks.

  • +1 more secondary outcomes

Study Arms (3)

Active tACS & active boosting group

ACTIVE COMPARATOR

The active tACS \& active boosting group will be stimulated with 10 sessions of active alternating current stimulation (tACS) and 5 booster sessions of active tACS.

Device: Active tACSDevice: Active boosting

Active tACS & sham boosting group

OTHER

The active tACS \& sham boosting group will be stimulated with 10 sessions of active alternating current stimulation (tACS) and 5 booster sessions of sham tACS.

Device: Active tACSDevice: Sham boosting

Sham tACS & sham boosting group

SHAM COMPARATOR

The sham tACS \& sham boosting group will be stimulated with 10 sessions of sham alternating current stimulation (tACS) and 5 booster sessions of sham tACS.

Device: Sham tACSDevice: Sham boosting

Interventions

Active tACSDEVICE

Placement of stimuli electrodes will be: a) active electrode over the left DLPFC (F3), and b) reference electrode over the right parietal region (P2). The exact location of electrodes will be determined by the 10/20 EEG method with EEG cap. Subjects will have tACS sessions on consecutive days (weekends and holidays excluded). Each subject will have 10 active tACS sessions.The active tACS group will be stimulated with a 2 mA current for 20 minutes.

Active tACS & active boosting groupActive tACS & sham boosting group
Sham tACSDEVICE

Placement of stimuli electrodes will be: a) active electrode over the left DLPFC (F3), and b) reference electrode over the right parietal region (P2). The exact location of electrodes will be determined by the 10/20 EEG method with EEG cap. Subjects will have tACS sessions on consecutive days (weekends and holidays excluded). Each subject will have 10 sham tACS sessions.The sham tACS group will have stimulation lasting only 40 seconds though the electrodes will remain in place for 20 min.

Sham tACS & sham boosting group
Active boostingDEVICE

Placement of stimuli electrodes will be: a) active electrode over the left DLPFC (F3), and b) reference electrode over the right parietal region (P2). The exact location of electrodes will be determined by the 10/20 EEG method with EEG cap. Subjects will have tACS sessions on consecutive days (weekends and holidays excluded).One month later after initial treatment, each subject will have 5 booster sessions of active tACS.The active boosting group will be stimulated with a 2 mA current for 20 minutes.

Active tACS & active boosting group
Sham boostingDEVICE

Placement of stimuli electrodes will be: a) active electrode over the left DLPFC (F3), and b) reference electrode over the right parietal region (P2). The exact location of electrodes will be determined by the 10/20 EEG method with EEG cap. Subjects will have tACS sessions on consecutive days (weekends and holidays excluded).One month later after initial treatment, each subject will have 5 booster sessions of sham tACS.The sham boosting group will have stimulation lasting only 40 seconds though the electrodes will remain in place for 20 min.

Active tACS & sham boosting groupSham tACS & sham boosting group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Chunbo Li, Ph.D.

    Shanghai Mental Health Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chunbo Li, Ph.D.

CONTACT

86-21-34773243chunbo_li@163.com

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

October 27, 2018

First Posted

November 28, 2018

Study Start

November 1, 2018

Primary Completion

December 1, 2019

Study Completion

March 1, 2020

Last Updated

November 28, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)