- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05165654
Improving Hallucinations by Targeting the rSTS With tES
Improving Hallucinations by Targeting the Right Superior Temporal Sulcus With Electrical Stimulation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Functional neuroimaging studies have identified neural correlates of hallucinations across multiple brain regions. Some studies suggest a common neuroanatomical substrate independent of the sensory modality, while others suggest different neural correlates for different types of hallucinations. However, whether these neuroimaging findings represented a cause, consequence or epiphenomenon of hallucinations was unclear until recently. Using lesion network mapping, researchers demonstrated that focal brain lesions play a causal role in the development of hallucinations and can occur in different brain locations, both inside and outside sensory pathway, and that greater than 90% of lesion locations causing hallucinations are negatively connected to the right superior temporal sulcus (rSTS). The rSTS is known to play a role in social cognition, biological motion, audiovisual integration, and speech. Hence, when spontaneous activity decreases at lesion locations causing hallucinations, spontaneous activity in the rSTS increases, the exact pattern thought to predispose to hallucinations. Additionally, functional connectivity within this region is abnormal in patients with visual and auditory hallucinations. Therefore, the association between rSTS connectivity and hallucinations would suggest this region may be optimal for modulation via non-invasive brain stimulation.
One method by which cortical excitability can be altered is with transcranial direct current stimulation (tDCS), a non-invasive brain stimulation technique. High definition tDCS (HD-tDCS) is a refined version of tDCS with improved spatial precision of cortical stimulation. This involves the application of a weak electrical current (1-2 mA) delivered to the brain via scalp electrodes. tDCS can modulate cortical excitability, where anodal stimulation tends to increase (i.e. the resting potential becomes less negative) and cathodal stimulation tends to decrease the underlying membrane potential (i.e. the resting potential becomes more negative). While tDCS is a promising adjunctive treatment of auditory hallucinations and negative symptoms in schizophrenia, less is known about its role in treating hallucinations overall. To date, no study has non-invasively stimulated the rSTS with tDCS in psychosis and examined its effects on hallucinations. However, there are studies in healthy volunteers showing that anodal stimulation to the STS resulted in increased auditory false perceptions, while cathodal stimulation decreased false perceptions and was lower than the sham condition. Taken together, the recent lesion network mapping identifying the rSTS as a major source of hallucinations combined with prior studies showing that the rSTS is associated with hallucinations suggest that it may be possible to alleviate hallucinations by designing a tDCS protocol that targets the rSTS with cathodal stimulation. Technological advances in noninvasive neuromodulation and electrical field modeling further allow us to create a tDCS protocol specifically guided by the results of lesion network mapping studies with high spatial resolution.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Paulo Lizano, MD, PhD
- Phone Number: (617) 754-1227
- Email: plizano@bidmc.harvard.edu
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Recruiting
- Beth Israel Deaconess Medical Center
-
Contact:
- Paulo Lizano, MD, PhD
- Phone Number: 617-754-1227
- Email: plizano@bidmc.harvard.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged 18-50 years of age
- Proficient in English
- Able to give informed consent
- Actively experiencing hallucinations (tactile, auditory, visual, etc.)
- Has not recently participated in tES/TMS treatments
Exclusion Criteria:
- Substance abuse or dependence (w/in past 6 months)
- Those who are pregnant/breastfeeding
- History of head injury with > 15 minutes of loss of consciousness/mal sequelae
- DSM-V intellectual disability
- Having a non-removable ferromagnetic metal within the body (particularly in the head)
- History of seizures
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Active Stimulation with TDCS
10 tDCS; Two, twenty-minute sessions of tDCS to the rSTS for 5 days (10 total sessions).
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Transcranial electrical stimulation
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Sham Comparator: SHAM Stimulation
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).
|
Transcranial electrical stimulation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Positive and Negative Syndrome Scale (PANSS)
Time Frame: Change from baseline to day 5
|
Measuring total psychosis symptoms score (Total score minimum = 30, maximum = 210); General symptoms (minimum score = 16, maximum score = 112); Negative Symptoms (minimum score = 16, maximum score = 112); and Positive Symptoms (minimum score = 16, maximum score = 112); higher scores represent higher severity of symptoms
|
Change from baseline to day 5
|
Positive and Negative Syndrome Scale (PANSS)
Time Frame: Change from baseline to month follow-up
|
Measuring total psychosis symptoms score (Total score minimum = 30, maximum = 210); General symptoms (minimum score = 16, maximum score = 112); Negative Symptoms (minimum score = 16, maximum score = 112); and Positive Symptoms (minimum score = 16, maximum score = 112); higher scores represent higher severity of symptoms
|
Change from baseline to month follow-up
|
University of Miami Parkinson's Disease Hallucinations Questionnaire (UM-PDHQ)
Time Frame: Change from baseline to day 5
|
Measuring severity and duration of hallucinations; 20-item questionnaire to be used as a screening instrument to assess hallucinations (6 quantitative and 14 qualitative items); higher scores represent higher severity of symptoms
|
Change from baseline to day 5
|
University of Miami Parkinson's Disease Hallucinations Questionnaire (UM-PDHQ)
Time Frame: Change from baseline to month follow-up
|
Measuring severity and duration of hallucinations; 20-item questionnaire to be used as a screening instrument to assess hallucinations (6 quantitative and 14 qualitative items); higher scores represent higher severity of symptoms
|
Change from baseline to month follow-up
|
7-item Auditory Hallucinations Rating Scale (AHRS)
Time Frame: Change from baseline to day 5
|
Measuring severity and duration of hallucinations; severity for each item is rated on a 7-point scale; higher scores represent higher severity of symptoms
|
Change from baseline to day 5
|
7-item Auditory Hallucinations Rating Scale (AHRS)
Time Frame: Change from baseline to month follow-up
|
Measuring severity and duration of hallucinations; severity for each item is rated on a 7-point scale; higher scores represent higher severity of symptoms
|
Change from baseline to month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Auditory Steady state evoked potential
Time Frame: Change from baseline to day 5
|
Measuring the average evoked response potential amplitude change to an auditory stimulus
|
Change from baseline to day 5
|
Auditory Steady state evoked potential
Time Frame: Change from baseline to month follow-up
|
Measuring the average evoked response potential amplitude change to an auditory stimulus
|
Change from baseline to month follow-up
|
Steady state visual evoked potential
Time Frame: Change from baseline to day 5
|
Measuring the average evoked response potential amplitude change to a visual stimulus
|
Change from baseline to day 5
|
Steady state visual evoked potential
Time Frame: Change from baseline to month follow-up
|
Measuring the average evoked response potential amplitude change to a visual stimulus
|
Change from baseline to month follow-up
|
Cross Modal Steady state evoked potential
Time Frame: Change from baseline to day 5
|
Measuring the average evoked response potential amplitude change to a combined auditory and visual stimulus
|
Change from baseline to day 5
|
Cross Modal Steady state evoked potential
Time Frame: Change from baseline to month follow-up
|
Measuring the average evoked response potential amplitude change to a combined auditory and visual stimulus
|
Change from baseline to month follow-up
|
Resting State EEG
Time Frame: Change from baseline to 5 day
|
Measuring neural activity at rest and connectivity
|
Change from baseline to 5 day
|
Resting State EEG
Time Frame: Change from baseline to month follow-up
|
Measuring neural activity at rest and connectivity
|
Change from baseline to month follow-up
|
Biological motion
Time Frame: Change from baseline to 5 day
|
Measuring the percent correct of detected motion by presenting a simulated walker; difficulty is increased by the level of random noise around stimuli
|
Change from baseline to 5 day
|
Biological motion
Time Frame: Change from baseline to month follow-up
|
Measuring the percent correct of detected motion by presenting a simulated walker; difficulty is increased by the level of random noise around stimuli
|
Change from baseline to month follow-up
|
Neurological Evaluation Scale; Sensory Integration
Time Frame: Change from baseline to 5 day
|
Measuring the percent correct of auditory and visual integration; auditory stimuli partners are matched to visual stimuli; difficulty is increased with more complex patterns
|
Change from baseline to 5 day
|
Neurological Evaluation Scale; Sensory Integration
Time Frame: Change from baseline to month follow-up
|
Measuring the percent correct of auditory and visual integration; auditory stimuli partners are matched to visual stimuli; difficulty is increased with more complex patterns
|
Change from baseline to month follow-up
|
Global assessment of function (GAF)
Time Frame: Change from baseline to day 5
|
Measuring global functioning; severity of symptoms related to day-to-day life on a scale of 0 to 100; higher scores represent higher severity of symptoms
|
Change from baseline to day 5
|
Global assessment of function (GAF)
Time Frame: Change from baseline to month follow-up
|
Measuring global functioning; severity of symptoms related to day-to-day life on a scale of 0 to 100; higher scores represent higher severity of symptoms
|
Change from baseline to month follow-up
|
Montgomery-Asberg Depression Rating Scale (MADRS)
Time Frame: Change from baseline to 5 day
|
Measuring total depression scores; 10 item scale related to depressive episodes (total score 0-60); higher scores represent higher severity of symptoms
|
Change from baseline to 5 day
|
Montgomery-Asberg Depression Rating Scale (MADRS)
Time Frame: Change from baseline to month follow-up
|
Measuring total depression scores; 10 item scale related to depressive episodes (total score 0-60); higher scores represent higher severity of symptoms
|
Change from baseline to month follow-up
|
Young Mania Rating Scale (YMRS)
Time Frame: Change from baseline to 5 day
|
Measuring total Mania scores; 11 items used to access severity of mania (total score 0-60); higher scores represent higher severity of symptoms
|
Change from baseline to 5 day
|
Young Mania Rating Scale (YMRS)
Time Frame: Change from baseline to month follow-up
|
Measuring total Mania scores; 11 items used to access severity of mania (total score 0-60); higher scores represent higher severity of symptoms
|
Change from baseline to month follow-up
|
Brief Assessment of Cognition (BACS)
Time Frame: Change from baseline to 5 day
|
Measuring cognition; cognitive domains assessed include memory, working memory, processing speed, executive functions and verbal fluency
|
Change from baseline to 5 day
|
Brief Assessment of Cognition (BACS)
Time Frame: Change from baseline to month follow-up
|
Measuring cognition; cognitive domains assessed include memory, working memory, processing speed, executive functions and verbal fluency
|
Change from baseline to month follow-up
|
Symptom Checklist-90
Time Frame: Change from baseline to 5 day
|
Measuring total psychiatric symptoms; 90 symptoms and evaluates nine symptomatic dimensions; higher scores represent higher severity of symptoms
|
Change from baseline to 5 day
|
Symptom Checklist-90
Time Frame: Change from baseline to month follow-up
|
Measuring total psychiatric symptoms; 90 symptoms and evaluates nine symptomatic dimensions; higher scores represent higher severity of symptoms
|
Change from baseline to month follow-up
|
Collaborators and Investigators
Investigators
- Principal Investigator: Paulo Lizano, MD, PhD, Beth Israel Deaconess Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019P001016X
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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