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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to month follow-up
Awards & highlights
Study Summary
This trial will test whether or not brain stimulation can help improve hallucinations in people with different neurological and psychiatric illnesses.
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.Check my eligibility
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.See study design
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 belowSelect...
I am currently experiencing hallucinations.
Select...
I am between 18 and 50 years old.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
7-item Auditory Hallucinations Rating Scale (AHRS)
Positive and Negative Syndrome Scale (PANSS)
University of Miami Parkinson's Disease Hallucinations Questionnaire (UM-PDHQ)
Secondary outcome measures
Auditory Steady state evoked potential
Biological motion
Brief Assessment of Cognition (BACS)
+8 moreTrial 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
Find a Location
Who is running the clinical trial?
Beth Israel Deaconess Medical CenterLead Sponsor
839 Previous Clinical Trials
13,010,420 Total Patients Enrolled
Paulo Lizano, MD, PhDPrincipal InvestigatorBeth Israel Deaconess Medical Center
1 Previous Clinical Trials
32 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently experiencing hallucinations.You have an intellectual disability according to the DSM-V guidelines.I am between 18 and 50 years old.I have a history of seizures.You have metal in your body that cannot be taken out, especially near your head.You have a history of head injury with more than 15 minutes of unconsciousness or lasting problems from the injury.You have struggled with substance abuse or addiction in the last 6 months.You have not received tES/TMS treatments recently.
Research Study Groups:
This trial has the following groups:- Group 1: SHAM Stimulation
- Group 2: Active Stimulation with TDCS
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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