High-Definition Transcranial Direct Current Stimulation as a Treatment of Negative Symptoms of Schizophrenia

NCT ID: NCT03602716

Last Updated: 2021-08-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-16
• Study Completion Date: 2020-09-26

Brief Summary

In this study, investigators designed a double-blind randomized trial to prove a more reliable evidence to show how the treatment by using high-definition transcranial direct current stimulation (HD-tDCS) can relieve negative symptoms in patients with predominant negative symptoms of schizophrenia, especially on improving participants' anhedonia condition and social cognition, through stimulating the left dorsolateral prefrontal cortex (DLPFC). Participants will be divided into active and sham HD-tDCS groups equally.

Detailed Description

Schizophrenia is one of the most disabling psychiatric disorders that almost 1% worldwide population suffer from this devastating illness. The clinical expression of this illness has been categorized into different dimensions, though most of the patients are well treated with antipsychotic medication, the negative symptom is still one of the very refractory symptoms. Emerging evidence shows that transcranial direct current stimulation (tDCS) is a promising treatment for schizophrenia negative symptoms, however, findings are still controversial. HD-tDCS can provide a more stable and accurate direct current comparing with traditional tDCS, which gives a hope to treat negative symptoms in a more reliable way.

An association between negative symptoms and grey matter reductions in the prefrontal cortex is found, moreover, even during rest, hypoactivity of the prefrontal cortex, particularly of the left dorsolateral, and of the anterior cingulate regions, has been linked to negative symptoms of schizophrenia. It has been observed that tDCS could relatively alleviate negative symptoms in patients with schizophrenia by stimulating the left DLPFC through an anodal electrode, which has been proved can also modulate brain functional connectivity and have clinical improvements.

Half of the participants with a clinical presentation of predominant negative symptoms will be stimulated by active HD-tDCS and the rest will have a sham stimulation. HD-tDCS is going to be delivered at 1.5 mA intensity for 20 minutes once a day; sessions will be performed on 10 days 5 consecutive weekdays with sustained effects at 1 (T2) and 3 (T3) months. A Soterix Medical 4x1 HD-tDCS will be used with the anode placed over the left DLPFC (F3), surrounded by four cathodal electrodes at F5, F1, FC3 and AF3, based on the 10/20 international EEG system. All the outcomes will be assessed at baseline (T0, before HD-tDCS sessions), one day after the 10th HD-tDCS sessions (T1), and also at T2 and T3. Both participants and investigators will be blind to this treatment.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

HD-tDCS group

This HD-tDCS group will be stimulated by active HD-tDCS.

Group Type: EXPERIMENTAL

HD-tDCS

Intervention Type: DEVICE

HD-tDCS is going to be delivered at 1.5 mA intensity for 20 minutes once a day (+15 s fade-in and fade-out); sessions will be performed on 10 days 5 consecutive weekdays with sustained effects at T1 and T2. HD-tDCS will be used with the anode placed over the left DLPFC (F3) surrounded by four cathodes at F5, F1, FC3, and AF3 based on the 10/20 international EEG system.

Sham HD-tDCS group

This sham HD-tDCS group will have a sham stimulation with HD-tDCS.

Group Type: SHAM_COMPARATOR

Sham HD-tDCS

Intervention Type: DEVICE

HD-tDCS is going to be used with the anode placed over the left DLPFC (F3) surrounded by four cathodes at F5, F1, FC3, and AF3 based on the 10/20 international EEG system; sessions will be performed on 10 days 5 consecutive weekdays with sustained effects at T1 and T2. This group will have a 20-min-sham stimulation.

Interventions

HD-tDCS

HD-tDCS is going to be delivered at 1.5 mA intensity for 20 minutes once a day (+15 s fade-in and fade-out); sessions will be performed on 10 days 5 consecutive weekdays with sustained effects at T1 and T2. HD-tDCS will be used with the anode placed over the left DLPFC (F3) surrounded by four cathodes at F5, F1, FC3, and AF3 based on the 10/20 international EEG system.

Intervention Type: DEVICE

Sham HD-tDCS

HD-tDCS is going to be used with the anode placed over the left DLPFC (F3) surrounded by four cathodes at F5, F1, FC3, and AF3 based on the 10/20 international EEG system; sessions will be performed on 10 days 5 consecutive weekdays with sustained effects at T1 and T2. This group will have a 20-min-sham stimulation.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• patients with diagnostic schizophrenia by DSM-IV
• patients at an age between 18-60 years of Han nationality
• 1) baseline score equal or higher than 4 in at least two items in negative symptoms at PANSS; 2) or baseline score equal or higher than 3 points in at least 1/3 items (including apathy) for negative symptoms; and 3)No more than 2 items have a score higher than 3 points for positive symptoms at PANSS.
• willing to participate in the experiment and take treatment

Exclusion Criteria

• other psychiatric diagnoses
• criteria for bipolar disorder; dementia; other psychotic disturbs; substance-related disorders
• schizophrenia caused by organic diseases
• other mental disorders caused by drugs and alcohol
• IQ<70
• presence of serious suicidal behaviour
• claustrophobic or pregnancy
• metal implantation in vivo
• specific tDCS limitations (such as anatomic problems and high sensitivity on current)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese Academy of Sciences

OTHER_GOV

Sponsor Role: collaborator

Shanghai Mental Health Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

17411970000

Identifier Type: -

Identifier Source: org_study_id