Brain Stimulation and Therapy for Schizophrenia

(tACS/CBTpSZ Trial)

Overseen By Adriana Farcas, PhD, Clinical Neuroscientist

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Felicia Iftene

Disqualifiers: Substance abuse, Suicidal ideation, Neurological condition, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 19

Duration: 16 weeks

28 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not require you to stop your current medications, but you should not have any changes in your medication regimen for at least one month before starting the trial. Minor dose adjustments or changes for symptoms like sleep or anxiety are allowed.

What data supports the effectiveness of the treatment tACS/CBTp for schizophrenia?

Research shows that transcranial alternating current stimulation (tACS), a non-invasive brain stimulation technique, has potential in treating schizophrenia by improving symptoms like hallucinations, delusions, and cognitive deficits. Studies have reported improvements in negative symptoms and cognitive functions, suggesting that tACS could be a promising treatment for schizophrenia. ^{1 2 3 4 5}

Is transcranial alternating current stimulation (tACS) safe for humans?

Research on transcranial alternating current stimulation (tACS) for schizophrenia shows it is generally well-tolerated with only mild, temporary side effects reported. Studies suggest it is safe for use in humans, though more large-scale trials are needed to confirm these findings. ^{1 2 3 4 6}

How does the tACS/CBTp treatment for schizophrenia differ from other treatments?

The tACS/CBTp treatment is unique because it combines transcranial alternating current stimulation (tACS), a noninvasive brain stimulation technique that uses low-intensity electrical currents to modulate brain activity, with cognitive behavioral therapy for psychosis (CBTp). This approach aims to improve cognitive deficits and reduce symptoms like hallucinations and delusions, offering a novel method compared to traditional medication-based treatments. ^{1 3 4 5 7}

What is the purpose of this trial?

The investigators are proposing a new, non-invasive therapeutic model using transcranial alternative current stimulation (tACS), to augment cognitive behavioral therapy for psychosis (CBTp) efficacy in individuals with schizophrenia (SZ). Using EEG brain oscillation activity, as a biomarker of the progression of cognitive deficits in SZ, the investigators aim to understand if addressing the oscillation perturbations could reduce the cognitive deficits. The investigators are using heart rate variability (HRV) as a biomarker of improvement of somatic and mental health. The investigators are aiming also for an analysis through a GBA+ lens, by using along with specific tests for psychosis (PANSS, NSA-16, etc.), the BEM Sex Role Inventory. Considering that cognitive and emotional status is gender dependent, the investigators expect that the therapeutic response could be gender specific. This is a prospective, randomized, repeated-measures, single-blind study design. Pre-intervention, eligible participants will be randomly assigned to one of two treatment arms. Arm 1 (tACS/CBTp n=14); Arm 2 (sham tACS/CBTp, n=14; tACS is sham, but CBTp is active). Intervention (16 weeks): participants in Arms 1 and 2 will receive once weekly tACS/ CBTp or sham tACS/CBTp. Post-intervention: follow-up visits at 4- and 12-weeks post-intervention (with a tACS/CBTp booster session provided each time). The chart review will search for: comorbid metabolic conditions, lab work abnormalities (glycemic level, Hb A, cholesterol), substances use, BMI, type of medication, side effects. Expected outcomes: Participants in Arm 1 will show a better improvement in psychosocial assessment scores, electrical brain activity (tendency to organize the neural oscillations in the gamma frequency range, mainly in frontal lobes) and heart activity (increased HRV). The timeline for recruitment, treatment and follow-up, is 18 months, followed by six months for data analysis, dissemination activities. Population: Individuals with SZ (DSM V criteria) stratified by age and sex. The investigators expect 150 potentially eligible patients from PCH-MHS, with 28 participants consenting to participate.

Research Team

Felicia Iftene, Associate Professor, Md, PhD

Principal Investigator

Department of Psychiatry, Queen's University

Eligibility Criteria

This trial is for individuals with schizophrenia or at high risk for psychosis. Participants must meet DSM V criteria for schizophrenia and can be stratified by age and sex. They should not have comorbid metabolic conditions, substance use issues, abnormal lab work (like blood sugar or cholesterol levels), or a body mass index outside the set range.

Inclusion Criteria

Provision of written informed consent

My medication has been stable for at least 1 month, with only minor adjustments.

I understand and can follow the study's requirements.

Exclusion Criteria

Current illicit drug substance abuse

Current suicidal ideation

I am currently participating in a structured therapy program.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Treatment

Participants receive weekly tACS/CBTp or sham tACS/CBTp sessions for 16 weeks

16 weeks

16 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment with booster sessions

12 weeks

2 visits (in-person)

Treatment Details

Interventions

• tACS/CBTp

Trial Overview The study tests if transcranial alternating current stimulation (tACS) before cognitive behavioral therapy for psychosis (CBTp) improves treatment outcomes in schizophrenia when added to usual medication. It's a single-blind study with two groups: one receiving real tACS/CBTp and another getting sham tACS but real CBTp over 16 weeks, plus follow-ups.

Participant Groups

Group I: tACS/CBTp, both active/ intervention Experimental Treatment 1 Intervention

n=14; participants living with schizophrenia/schizoaffective disorder, stable under their usual medication; tACS (gamma band electric stimulation) will be applied the first 20 minutes of the CBTp session (then the device remains in place, but the electric stimulation will be automatically stopped). The CBTp will continue up until a total of 50 minutes/session.

Group II: Sham tACS and CBTp (only CBTp active, intervention) Placebo Group 1 Intervention

n=14, same diagnosis population, gender and age matched; sham tACS, CBTp for 50 minutes/session.

Who Is Running the Clinical Trial?

Felicia Iftene

Lead Sponsor

Trials

1

Recruited

30+

Felicia Iftene

Lead Sponsor

Providence Care Hospital - Providence Care

Collaborator

Trials

1

Recruited

30+

Kingston Health Sciences Centre

Collaborator

Trials

312

Recruited

112,000+

Queen's University

Collaborator

Trials

382

Recruited

122,000+

Queen's University

Collaborator

References

1. England pubmed.ncbi.nlm.nih.gov

Efficacy of transcranial alternating current stimulation for schizophrenia treatment: A systematic review. [2023]

2. France pubmed.ncbi.nlm.nih.gov

Gamma transcranial alternating current stimulation in patients with negative symptoms in schizophrenia: A case series. [2021]

3. Korea (South) pubmed.ncbi.nlm.nih.gov

Transcranial Alternating Current Stimulation (tACS) and Its Role in Schizophrenia: A Scoping Review. [2023]

4. Austria pubmed.ncbi.nlm.nih.gov

Effects of theta-rhythm transcranial alternating current stimulation (4.5 Hz-tACS) in patients with clozapine-resistant negative symptoms of schizophrenia: a case series. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Feasibility of Online Neuromodulation Using Transcranial Alternating Current Stimulation in Schizophrenia. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Targeting reduced neural oscillations in patients with schizophrenia by transcranial alternating current stimulation. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Online Theta Frequency Transcranial Alternating Current Stimulation for Cognitive Remediation in Schizophrenia: A Case Report and Review of Literature. [2020]