Transcranial Alternating Current Stimulation (tACS) for Cognitive Impairments in Patients With Schizophrenia

Schizophrenia Clinical Trial

Official title:

Transcranial Alternating Current Stimulation (tACS) for Cognitive Impairments in Patients With Schizophrenia: a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03756610
• Other study ID #: 2018-24
• Status: Recruiting
• Phase: N/A
• Start date: November 2018
• Est. completion date: March 2020

Study information

• Verified date: October 2018
• Source: Shanghai Mental Health Center
• Contact: Chunbo Li, Ph.D.
• Phone: 86-21-34773243
• Email: chunbo_li[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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. Alternating current stimulation (tACS) 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. The ability to entrain γ oscillations with 40Hz tACS, might compensate more specifically for this deficit in γ oscillations in schizophrenia, and, may therefore, produce more robust behavioral improvements in working memory and other aspects of cognition.However, no studies have looked at the effects of multiple daily tACS stimulation at a 40HZ γ frequency on cognitive function and symptoms in schizophrenia. This provides a rationale for the current study, which proposes to investigate the effects of 10 sessions of 40HZ tACS on cognitive functions, symptoms in schizophrenia.

Active vs. sham treatment will be randomly assigned in a 2:1 fashion (A:S) in groups using computer generated lists. Subjects and tDCS testers or evaluators will be blind to treatment. Subjects will be evaluated with cognitive, symptom and functional measures at baseline, within 1 day ( or 2 days fro some measures) after 10 sessions, 2 weeks after 10 sessions, 1 month after 10 sessions, and 2 months after 10 sessions.After the 1 month evaluation, subjects in the initial active tACS group will be randomly assigned to receive either 5 booster sessions of either active or sham tACS ( 25 subjects each), following parameters used in the initial treatment. Subjects in the initial Sham group will receive 5 booster session Sham tACS. Participants will be scanned once prior to tACS sessions, and within 3 days after the 10th tACS session, using our Siemens 3T Tim Verio MRI scanner with a standard 32-channel phased-array head coil.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: March 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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).

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Schizophrenia

Intervention

Device:
• Active tACS
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.
• Sham tACS
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.
• Active boosting
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.
• Sham boosting
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.

Locations

Country	Name	City	State
China	Shanghai Mental Health Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Mental Health Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in The MATRICS Consensus Cognitive Battery (MCCB)		Change from Baseline MCCB at 2 weeks.
Primary	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.
Primary	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	N-back task	to test working memory	At baseline,1-week, 2-week, 4-week, and 8-week follow-up.
Secondary	The Paced Auditory Serial Addition Task (PASAT)	to test Verbal Working memory	At baseline,2-week, 4-week, and 8-week follow-up.
Secondary	The Positive and Negative Syndrome Scale (PANSS)	PANSS was assessed using 30 basic items to form three subscales: positive, negative, and general psychopathological scales.The value of each item is ranging from 1 to 7, higher values represent more serious symptoms of schizophrenia.	At baseline,2-week, 4-week, and 8-week follow-up.
Secondary	The USCD Performance- Based Skills Assessment Battery (UPSA)		At baseline,2-week, 4-week, and 8-week follow-up.
Secondary	Side-effects of tACS		At each stimulation session,up to 2 weeks.
Secondary	The MATRICS Consensus Cognitive Battery (MCCB)		At 4-week and 8-week follow-up.