Schizophrenia and Related DisordersNCT04248010
Mechanistic Clinical Trial of Individualized tDCS for Hallucinations in Schizophrenia
A study testing neuroConn DC-Stimulator MR and Soterix MxN HD-tES in people with Schizophrenia and Related Disorders, run by Columbia University.
Trial summary
This project compares standard tDCS to individualized high-definition tDCS (HD-tDCS) for treatment of auditory verbal hallucinations in schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Schizophrenia and Related Disorders
- What is being tested?
- neuroConn DC-Stimulator MR and Soterix MxN HD-tES
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2022to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- DSM-V diagnosis of schizophrenia or schizoaffective disorder
- Capacity and willingness to provide informed consent
- Mean AHRS item score of greater or equal to 2.
- If female and not infertile, must agree to use one of the following forms of contraception for the duration of study participation: systemic hormonal treatment, an IUD which was implanted at least 2 months prior to screening, or "double-barrier" contraception. Women of child bearing potential must have a negative pregnancy test at screening
- Right handed
- Normal hearing
- Taking an antipsychotic medication at a stable dose for at least 4 weeks. All oral and depot antipsychotics are allowable.
Who cannot join
- Presence or positive history of unstable significant medical or neurological illness
- Substance use disorder (excluding nicotine) within last 90 days, or positive toxicology screen for any substance of abuse
- Pregnancy
- Participation in study of investigational medication/device within 4 weeks
- History of seizure, epilepsy in self or first-degree relatives, stroke, brain surgery, head injury with loss of consciousness >1 hour or clear cognitive sequelae, intracranial metal implants, known structural brain lesion, devices that may be affected by tDCS (pacemaker, medication pump, cochlear implant, implanted brain stimulator)
- Subjects with suicidal ideation with intent or plan (indicated by affirmative answers to items 4 or 5 of the Suicidal Ideation section of the baseline C-SSRS) in the 6 months prior to screening or subjects who represent a significant risk of suicide in the opinion of the investigator
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- Frequent and persistent migraines
- Clinically significant skin disease
- Current use of medications known to lower seizure threshold (Lithium, Theophyline, Tricyclic antidepressants, Buproprion >450 mg/day and Clozapine >600 mg/day, brand name and generic methylphenidate/mixed amphetamine salts)
- History of prior clinically significant, adverse response to neurostimulation or open skin wounds that would preclude safe placement of tDCS electrodes
- Contraindication to MRI scanning, including metal implants or claustrophobia. Metal implants, pacemaker, other metal (e.g., shrapnel or surgical prostheses) or paramagnetic objects contained within the body which may present a risk to the subject or interfere with MR scan
- Medicinal patch, unless removed
About this study
This project compares standard tDCS to individualized high-definition tDCS (HD-tDCS) for treatment of auditory verbal hallucinations in schizophrenia.
Read the detailed description
The large majority of patients with schizophrenia (Sz) experience auditory verbal hallucinations (AVH) as a core feature of their disorder. Treatment-resistant auditory verbal hallucinations (AVH) affect a third of patients with schizophrenia and can cause increased aggression, distress, suicide, and social dysfunction. This project will investigate the efficacy of different types of transcranial direct current stimulation (tDCS), a neurostimulation technique that passes a weak electric current through the brain, in alleviating AVH in Sz patients, and will explore hypotheses regarding brain circuits involved in AVH.
This project compares standard tDCS to individualized high-definition tDCS (HD-tDCS) for treatment of AVH. In standard tDCS, two large electrodes are positioned on the scalp above regions of the brain implicated in abnormal cortical activity associated with auditory verbal hallucinations in Sz. Due to the size of standard tDCS electrodes and the positions required to stimulate language areas, large unrelated areas of the brain are also stimulated. HD-tDCS is a novel technique that uses multiple smaller electrodes to produce a more focal electrical field (EF) than standard tDCS. The HD-tDCS used in this study modulates brain activity in a targeted area without stimulating as many unrelated areas. This targeted inhibition allows us to test hypotheses regarding different cortical regions and their roles in specific features of AVH (e.g. loudness and salience).
Participants are randomized to receive either active standard tDCS or active HD-tDCS targeting one of two language-processing areas of the brain, or a sham version of one of these stimulation types. For each participant receiving HD-tDCS, structural MRI is used to computationally model the electrical field produced in their individual brain anatomy by tDCS. These models are then used to select individualized electrode configurations and current settings to target the same language areas across subjects. The effect of stimulation on relevant brain functions is verified by measuring pre/post treatment changes in resting state functional connectivity (rsFC) within and between targeted language regions, which has been previously linked to AVH symptoms. Differences in behavioral task performance and neurophysiological abnormalities associated with AVH are also tested pre/post treatment.
- Conditions
- Schizophrenia and Related Disorders
- Being tested
- neuroConn DC-Stimulator MR, Soterix MxN HD-tES
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neuroConn DC-Stimulator MRDevice
standard tDCS, active \& sham
Soterix MxN HD-tESDevice
HD-tDCS, active \& sham
| Study group | Role | What they receive |
|---|---|---|
| standard tDCS | Active comparator | 20 min of standard 2-electrode transcranial direct current stimulation (2 mA) at a previously reported scalp location. Receives: Device: neuroConn DC-Stimulator MR |
| HD-tDCS - anterior target | Active comparator | 20 min of individualized high-density 5-electrode transcranial direct current stimulation to anterior language areas of the brain. Receives: Device: Soterix MxN HD-tES |
| HD-tDCS - posterior target | Active comparator | 20 min of individualized high-density 5-electrode transcranial direct current stimulation to posterior language areas of the brain. Receives: Device: Soterix MxN HD-tES |
| sham tDCS | Sham comparator | sham transcranial direct current stimulation using a brief pulse at the beginning and end of the 20 min intervention. Receives: Device: neuroConn DC-Stimulator MR; Device: Soterix MxN HD-tES |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Auditory Hallucination Rating Scale (AHRS)
Questionnaire-based assessment instrument for auditory verbal hallucinations, completed by study personnel.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study startDec 2022 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Why it stopped: Modifications in methodology had to be made that make the current registration invalid.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia and Related DisordersStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will receive one of the following: standard tDCS, HD-tDCS - anterior target, HD-tDCS - posterior target, or sham.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Avissar, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04248010
- Sponsor's protocol ID
- 7882
- Status last verified
- Mar 2022
- First submitted
- 27 Jan 2020
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanistic Clinical Trial of Individualized tDCS for Hallucinations in Schizophrenia
- ClinicalTrials.gov ID
- NCT04248010
- Acronym / sponsor ID
- 7882
- Conditions
- Schizophrenia and Related Disorders
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Modifications in methodology had to be made that make the current registration invalid.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- Dec 2022 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 30 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project compares standard tDCS to individualized high-definition tDCS (HD-tDCS) for treatment of auditory verbal hallucinations in schizophrenia.
Detailed description
The large majority of patients with schizophrenia (Sz) experience auditory verbal hallucinations (AVH) as a core feature of their disorder. Treatment-resistant auditory verbal hallucinations (AVH) affect a third of patients with schizophrenia and can cause increased aggression, distress, suicide, and social dysfunction. This project will investigate the efficacy of different types of transcranial direct current stimulation (tDCS), a neurostimulation technique that passes a weak electric current through the brain, in alleviating AVH in Sz patients, and will explore hypotheses regarding brain circuits involved in AVH.
This project compares standard tDCS to individualized high-definition tDCS (HD-tDCS) for treatment of AVH. In standard tDCS, two large electrodes are positioned on the scalp above regions of the brain implicated in abnormal cortical activity associated with auditory verbal hallucinations in Sz. Due to the size of standard tDCS electrodes and the positions required to stimulate language areas, large unrelated areas of the brain are also stimulated. HD-tDCS is a novel technique that uses multiple smaller electrodes to produce a more focal electrical field (EF) than standard tDCS. The HD-tDCS used in this study modulates brain activity in a targeted area without stimulating as many unrelated areas. This targeted inhibition allows us to test hypotheses regarding different cortical regions and their roles in specific features of AVH (e.g. loudness and salience).
Participants are randomized to receive either active standard tDCS or active HD-tDCS targeting one of two language-processing areas of the brain, or a sham version of one of these stimulation types. For each participant receiving HD-tDCS, structural MRI is used to computationally model the electrical field produced in their individual brain anatomy by tDCS. These models are then used to select individualized electrode configurations and current settings to target the same language areas across subjects. The effect of stimulation on relevant brain functions is verified by measuring pre/post treatment changes in resting state functional connectivity (rsFC) within and between targeted language regions, which has been previously linked to AVH symptoms. Differences in behavioral task performance and neurophysiological abnormalities associated with AVH are also tested pre/post treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Participants will receive one of the following: standard tDCS, HD-tDCS - anterior target, HD-tDCS - posterior target, or sham.
| Arm | Type | Receives |
|---|---|---|
| standard tDCS | Active comparator | Device: neuroConn DC-Stimulator MR20 min of standard 2-electrode transcranial direct current stimulation (2 mA) at a previously reported scalp location. |
| HD-tDCS - anterior target | Active comparator | Device: Soterix MxN HD-tES20 min of individualized high-density 5-electrode transcranial direct current stimulation to anterior language areas of the brain. |
| HD-tDCS - posterior target | Active comparator | Device: Soterix MxN HD-tES20 min of individualized high-density 5-electrode transcranial direct current stimulation to posterior language areas of the brain. |
| sham tDCS | Sham comparator | Device: neuroConn DC-Stimulator MR, Device: Soterix MxN HD-tESsham transcranial direct current stimulation using a brief pulse at the beginning and end of the 20 min intervention. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- DSM-V diagnosis of schizophrenia or schizoaffective disorder
- Capacity and willingness to provide informed consent
- Mean AHRS item score of greater or equal to 2.
- If female and not infertile, must agree to use one of the following forms of contraception for the duration of study participation: systemic hormonal treatment, an IUD which was implanted at least 2 months prior to screening, or "double-barrier" contraception. Women of child bearing potential must have a negative pregnancy test at screening
- Right handed
Key exclusion criteria (12 listed)
- Presence or positive history of unstable significant medical or neurological illness
- Substance use disorder (excluding nicotine) within last 90 days, or positive toxicology screen for any substance of abuse
- Pregnancy
- Participation in study of investigational medication/device within 4 weeks
- History of seizure, epilepsy in self or first-degree relatives, stroke, brain surgery, head injury with loss of consciousness >1 hour or clear cognitive sequelae, intracranial metal implants, known structural brain lesion, devices that may be affected by tDCS (pacemaker, medication pump, cochlear implant, implanted brain stimulator)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neuroConn DC-Stimulator MRstandard tDCS, active \& sham | Device | sham tDCS, standard tDCS |
| Soterix MxN HD-tESHD-tDCS, active \& sham | Device | HD-tDCS - anterior target, HD-tDCS - posterior target, sham tDCS |
Primary outcome
The Auditory Hallucination Rating Scale (AHRS)
Time frame: 1 week
Questionnaire-based assessment instrument for auditory verbal hallucinations, completed by study personnel.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing neuroConn DC-Stimulator MR and Soterix MxN HD-tES in people with Schizophrenia and Related Disorders, run by Columbia University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Auditory Hallucination Rating Scale (AHRS) (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2022.