What side effects are associated with this type of intervention?

Noninvasive brain stimulation techniques, such as transcranial magnetic stimulation (TMS), are being studied for the treatment of auditory hallucinations. Common side effects of TMS include mild discomfort at the stimulation site, headaches, scalp discomfort, and tingling or spasms in facial muscles. Serious adverse events are rare but can include the risk of seizures, particularly in patients with epilepsy. Overall, these treatments are generally well-tolerated with a low incidence of severe side effects.

What prior FDA approvals exist?

Transcranial magnetic stimulation (TMS) has been studied for its efficacy in treating auditory hallucinations, particularly in psychotic disorders such as schizophrenia and bipolar disorder. While the context does not specify FDA approvals for TMS specifically for auditory hallucinations, TMS is FDA-approved for treatment-resistant depression, which may include patients experiencing auditory hallucinations. Other noninvasive brain stimulation techniques, such as transcranial direct current stimulation (tDCS), are being explored for their potential benefits in modulating brain activity and sensory integration, but specific FDA approvals for these methods in the context of auditory hallucinations are not detailed in the provided information.

What other types of research exist?

Promising novel alternatives to noninvasive brain stimulation for treating auditory hallucinations include: 1) Cognitive Behavioral Therapy (CBT) tailored for psychosis, which helps patients manage and reduce the distress associated with hallucinations. 2) Antipsychotic medications, particularly newer atypical antipsychotics, which can be effective in reducing the frequency and severity of hallucinations. 3) Digital therapeutics, such as mobile apps and virtual reality, designed to provide therapeutic interventions and coping strategies for managing hallucinations. 4) Neuromodulation techniques like transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS), which continue to evolve and show promise in clinical trials.

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Noninvasive Brain Stimulation

Transcranial Electrical Stimulation for Hallucinations

N/A

Recruiting

Led By Paulo Lizano, MD, PhD

Research Sponsored by Beth Israel Deaconess Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Actively experiencing hallucinations (tactile, auditory, visual, etc.)

Aged 18-50 years of age

Must not have

History of seizures

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline to month follow-up

Summary

This trial uses a technique that applies a weak electrical current to the scalp to help patients with psychotic disorders who experience hallucinations. The treatment targets a specific brain area involved in processing sensory information to reduce abnormal activity and alleviate hallucinations. This non-invasive brain stimulation technique enhances the precision of the treatment by using smaller electrodes.

Who is the study for?

This trial is for English-speaking adults aged 18-50 who are currently experiencing hallucinations. It's not suitable for those with recent substance abuse, pregnant or breastfeeding individuals, people with significant head injuries, intellectual disabilities, metal implants in the body (especially in the head), or a history of seizures.

What is being tested?

The study tests Transcranial Electrical Stimulation (tES) targeted at the right superior temporal sulcus (rSTS) to see if it can improve brain activity and reduce hallucinations in psychotic disorders like schizophrenia.

What are the potential side effects?

Potential side effects of tES may include discomfort at the stimulation site, headache, dizziness, nausea or itching under the electrodes during application. There's also a low risk of inducing seizures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am currently experiencing hallucinations.

Select...

I am between 18 and 50 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a history of seizures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline to month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline to month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to month follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

7-item Auditory Hallucinations Rating Scale (AHRS)

Positive and Negative Syndrome Scale (PANSS)

University of Miami Parkinson's Disease Hallucinations Questionnaire (UM-PDHQ)

Secondary study objectives

Auditory Steady state evoked potential

Biological motion

Brief Assessment of Cognition (BACS)

+8 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active Stimulation with TDCSExperimental Treatment1 Intervention

10 tDCS; Two, twenty-minute sessions of tDCS to the rSTS for 5 days (10 total sessions).

Group II: SHAM StimulationPlacebo Group1 Intervention

10 passive sham control; Two, twenty-minute sessions of passive sham control to the rSTS for a 30 second ramped up and down at the beginning and end of the 20 min period for 5 days (10 total sessions).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Transcranial Electrical Stimulation

2019

Completed Early Phase 1

~20

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Noninvasive brain stimulation techniques like transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS) are commonly used to treat auditory hallucinations. TMS uses magnetic fields to stimulate nerve cells in specific brain regions, such as the dorsolateral prefrontal cortex, which can help modulate abnormal brain activity associated with hallucinations. tDCS, on the other hand, uses a low electrical current to alter neuronal activity and improve connectivity in targeted areas of the brain. These treatments matter for patients with auditory hallucinations because they offer a noninvasive way to potentially reduce the frequency and severity of hallucinations by directly influencing brain function and sensory processing.