SchizophreniaNCT01607840
Effects of Transcranial Direct Current Stimulation in Individuals With Schizophrenia
A study testing transcranial direct current stimulation in people with Schizophrenia, run by Johns Hopkins University at 1 site in United States.
Trial summary
This research is being done to determine whether transcranial direct current stimulation (tDCS) can improve certain mental abilities and alter functional connectivity in individuals with Schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- transcranial direct current stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Sep 2014
- 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Schizophrenia
- English as a native language
Who cannot join
- appreciable deficits in hearing or vision
- appreciable accent
- any implanted metal device or pacemaker
- Dementia or Mini Mental Exam below 24
- History of Seizures
Trial locations and contacts
1 site in 1 country.
About this study
This research is being done to determine whether transcranial direct current stimulation (tDCS) can improve certain mental abilities and alter functional connectivity in individuals with Schizophrenia. In this research, a 9 volt battery is used to deliver very weak electrical current to the surface of the scalp while participants complete cognitive tasks. Participants also receive a brain scan before and after stimulation. Our aim is to determine if tDCS can improve mental abilities in individuals with schizophrenia.
Read the detailed description
Participants enrolled into this study may be asked to do the following:
Grant permission for the researchers to view medical records associated with their language/cognitive difficulties
Complete a questionnaire, provide a health history, and take some pencil-and-paper tests of problem-solving and memory in order to verify eligibility to participate and to able to safely undergo the experimental procedures.
Complete several tasks (e.g., saying words out loud, naming objects, drawing designs, remembering lists of words, searching for images or letters, and/or completing puzzles) based upon a number of cognitive functions such as language, memory, vision, processing, and perception.
Wear electrodes that will be placed on the scalp with a large rubberized band. These electrodes will administer very weak electrical current (tDCS) from a 9 volt battery for 20 to 60 minutes.
Participation in several study conditions. The exact conditions and their order will be randomized. Under some conditions, participants may receive active stimulation (tDCS) and under other conditions, they may receive sham stimulation.
The experimental sessions will last approximately 2 hours and participants may be asked to have more than one testing session in a day or to return for additional sessions.
Have a Magnetic Resonance Imaging (MRI) brain scan.
- Conditions
- Schizophrenia
- Being tested
- transcranial direct current stimulation
- Keywords
- Schizophrenia, Cognitive Improvement, tDCS, stimulation
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulationProcedure or surgery
delivery of transcranial direct current stimulation or sham for 20 to 60 minutes
| Study group | Role | What they receive |
|---|---|---|
| Anodal Stimulation | Experimental | transcranial direct current stimulation using Anodal stimulation over the area of interest Receives: Procedure: transcranial direct current stimulation |
| Cathodal | Experimental | transcranial direct current stimulation using cathodal stimulation over the brain area of interest Receives: Procedure: transcranial direct current stimulation |
| Sham Stimulation | Sham comparator | transcranial direct current stimulation that is ramped up and ramped down providing the sensation of tDCS without actually delivering tDCS Receives: Procedure: transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Test Performance
Cognitive test performance by subjects will be evaluated upon completion of enrollment to determine if tDCS improved performance on cognitive tests.
Measured: The average time frame is approximately 2 hours
Secondary outcomes (1)
Functional Connectivity Changes Associated with tDCS
Pre- and post- stimulation MRI's will be conducted to determine if tDCS is associated with changes in neural activity.
Measured: Time frame is approximately 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2012 (estimated)
- Study startJun 2012
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barry Gordon, M.D., Ph.D., Johns Hopkins University
- Investigators
- Barry Gordon, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01607840
- Sponsor's protocol ID
- 15657-S
- Status last verified
- Aug 2015
- First submitted
- 24 May 2012
- Last updated
- 1 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcranial Direct Current Stimulation in Individuals With Schizophrenia
- ClinicalTrials.gov ID
- NCT01607840
- Acronym / sponsor ID
- 15657-S
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Cognitive Improvement, tDCS, stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 30 May 2012 (estimated)
- 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 research is being done to determine whether transcranial direct current stimulation (tDCS) can improve certain mental abilities and alter functional connectivity in individuals with Schizophrenia. In this research, a 9 volt battery is used to deliver very weak electrical current to the surface of the scalp while participants complete cognitive tasks. Participants also receive a brain scan before and after stimulation. Our aim is to determine if tDCS can improve mental abilities in individuals with schizophrenia.
Detailed description
Participants enrolled into this study may be asked to do the following:
Grant permission for the researchers to view medical records associated with their language/cognitive difficulties
Complete a questionnaire, provide a health history, and take some pencil-and-paper tests of problem-solving and memory in order to verify eligibility to participate and to able to safely undergo the experimental procedures.
Complete several tasks (e.g., saying words out loud, naming objects, drawing designs, remembering lists of words, searching for images or letters, and/or completing puzzles) based upon a number of cognitive functions such as language, memory, vision, processing, and perception.
Wear electrodes that will be placed on the scalp with a large rubberized band. These electrodes will administer very weak electrical current (tDCS) from a 9 volt battery for 20 to 60 minutes.
Participation in several study conditions. The exact conditions and their order will be randomized. Under some conditions, participants may receive active stimulation (tDCS) and under other conditions, they may receive sham stimulation.
The experimental sessions will last approximately 2 hours and participants may be asked to have more than one testing session in a day or to return for additional sessions.
Have a Magnetic Resonance Imaging (MRI) brain scan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anodal Stimulation | Experimental | Procedure: transcranial direct current stimulationtranscranial direct current stimulation using Anodal stimulation over the area of interest |
| Cathodal | Experimental | Procedure: transcranial direct current stimulationtranscranial direct current stimulation using cathodal stimulation over the brain area of interest |
| Sham Stimulation | Sham comparator | Procedure: transcranial direct current stimulationtranscranial direct current stimulation that is ramped up and ramped down providing the sensation of tDCS without actually delivering tDCS |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of Schizophrenia
- English as a native language
Key exclusion criteria (5 listed)
- appreciable deficits in hearing or vision
- appreciable accent
- any implanted metal device or pacemaker
- Dementia or Mini Mental Exam below 24
- History of Seizures
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 |
|---|---|---|
| transcranial direct current stimulationdelivery of transcranial direct current stimulation or sham for 20 to 60 minutes | Procedure or surgery | Anodal Stimulation, Cathodal, Sham Stimulation |
Primary outcome
Cognitive Test Performance
Time frame: The average time frame is approximately 2 hours
Cognitive test performance by subjects will be evaluated upon completion of enrollment to determine if tDCS improved performance on cognitive tests.
1 secondary outcome
Functional Connectivity Changes Associated with tDCS
Time frame: Time frame is approximately 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2015.
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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.
Barry Gordon principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial direct current stimulation in people with Schizophrenia, run by Johns Hopkins University at 1 site in United States.
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 1 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cognitive Test Performance (time frame: The average time frame is approximately 2 hours). 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 1 Sep 2015.