SchizophreniaNCT01378078
Transcranial Direct Current Stimulation (tDCS) for Treatment of Negative Syndrome in Patients With Schizophrenia
A study testing eldith DC-stimulator (neuroconn, Ilmenau, Germany) in people with Schizophrenia, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial summary
Transcranial direct current stimulation (tDCS) showed beneficial effects on cognition in healthy subjects and depressed patients. In this study, patients with treatment resistant negative syndrome in schizophrenia will be treated with direct current stimulation. fMRI measures will be performed. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- eldith DC-stimulator (neuroconn, Ilmenau, Germany)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2011to Jun 2013
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- schizophrenic patients with a negative syndrome. PANSS > 40.
Who cannot join
- other psychiatric or neurologic diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Transcranial direct current stimulation (tDCS) showed beneficial effects on cognition in healthy subjects and depressed patients. In this study, patients with treatment resistant negative syndrome in schizophrenia will be treated with direct current stimulation. fMRI measures will be performed.
- Conditions
- Schizophrenia
- Being tested
- eldith DC-stimulator (neuroconn, Ilmenau, Germany)
- Keywords
- schizophrenia, negative syndrome, PANSS
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eldith DC-stimulator (neuroconn, Ilmenau, Germany)Device
daily tDCS treatment over left DLPFC, 20 min, 2 mA
eldith DC-stimulator (Neuroconn, Ilmenau, Germany)Device
same as sham stimulation
| Study group | Role | What they receive |
|---|---|---|
| sham | Sham comparator | patients receive sham tDCS stimulation Receives: Device: eldith DC-stimulator (neuroconn, Ilmenau, Germany) |
| active | Active comparator | active transcranial direct current stimulation Receives: Device: eldith DC-stimulator (Neuroconn, Ilmenau, Germany) |
What is being measured
The primary outcome is the main question the study is designed to answer.
SANS reduction
decrease by 30%
Measured: 4 weeks after baseline
Secondary outcomes (1)
neuropsychological tests
increase in SOPT by 30% increase in TMT by 30%
Measured: 4 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionJun 2013
- Study completionJun 2013
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.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Keeser, Ludwig-Maximilians - University of Munich
- Investigators
- Ulrich Palm, MD, Principal investigator, Ludwig Maximilian University Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01378078
- Sponsor's protocol ID
- 04/2011
- Status last verified
- Jul 2013
- First submitted
- 16 Jun 2011
- Last updated
- 22 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation (tDCS) for Treatment of Negative Syndrome in Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT01378078
- Acronym / sponsor ID
- 04/2011
- Conditions
- Schizophrenia
- Keywords
- schizophrenia, negative syndrome, PANSS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 22 Jun 2011 (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.
Transcranial direct current stimulation (tDCS) showed beneficial effects on cognition in healthy subjects and depressed patients. In this study, patients with treatment resistant negative syndrome in schizophrenia will be treated with direct current stimulation. fMRI measures will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sham | Sham comparator | Device: eldith DC-stimulator (neuroconn, Ilmenau, Germany)patients receive sham tDCS stimulation |
| active | Active comparator | Device: eldith DC-stimulator (Neuroconn, Ilmenau, Germany)active transcranial direct current stimulation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- schizophrenic patients with a negative syndrome. PANSS > 40.
Key exclusion criteria (1 listed)
- other psychiatric or neurologic diseases.
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 |
|---|---|---|
| eldith DC-stimulator (neuroconn, Ilmenau, Germany)daily tDCS treatment over left DLPFC, 20 min, 2 mA | Device | sham |
| eldith DC-stimulator (Neuroconn, Ilmenau, Germany)same as sham stimulation | Device | active |
Primary outcome
SANS reduction
Time frame: 4 weeks after baseline
decrease by 30%
1 secondary outcome
neuropsychological tests
Time frame: 4 weeks after baseline
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 22 Jul 2013.
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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.
Ulrich Palm, MD principal investigator
Ludwig Maximilian University Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eldith DC-stimulator (neuroconn, Ilmenau, Germany) in people with Schizophrenia, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
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 1 inclusion and 1 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 22 Jul 2013. 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 Germany. 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?
SANS reduction (time frame: 4 weeks after baseline). 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 22 Jul 2013; AzTrials last refreshed its copy on 7 Nov 2026.