Anodal Stimulation tDCSNCT02823639
Efficacy and Mechanisms of Transcranial Direct Current Stimulation (tDCS) - Effects on Working Memory in Schizophrenia
A study testing Transcranial direct current stimulation in people with Anodal Stimulation tDCS and Schizophrenia, run by University Hospital Tuebingen at 2 sites in Germany.
Trial summary
Impairments of cognition are a core, severely disabling feature of schizophrenia leading to poor long-term outcome with no established treatment available. Particularly impaired executive functions (e.g working memory) are frequently observed and are consistently associated with reduced activation of the dorsolateral… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Anodal Stimulation tDCS, Schizophrenia, Working Memory
- 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
- 128 participants
- Where
- 2 sitesGermany
- Study dates
- Oct 2015to Oct 2022
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- diagnosed schizophrenia (DSM-V)
- age (18 - 60 years)
- right handedness
- stable medication during 1 week of treatment and 1 week before
Who cannot join
- history of seizures
- metal device throughout the body
- pregnancy
- use of anticonvulsive medication
- use of benzodiazepines more than 1 mg of Lorazepam equivalent
- current substance abuse (nicotine excluded)
Trial locations and contacts
2 sites in 1 country.
Germany2 sites, 2 recruiting
- Recruiting
LMU Muenchen, Department of Psychiatry and Psychotherapy
München
Alkomiet Hasan, MD
- Recruiting
University Hospital Tuebigen, Department of Psychiatry and Psychotherapy
Tübingen, 72076
Christian Plewnia, MD, +49 7071 29 86121, christian.plewnia@uni-tuebingen.de
About this study
Impairments of cognition are a core, severely disabling feature of schizophrenia leading to poor long-term outcome with no established treatment available.
Particularly impaired executive functions (e.g working memory) are frequently observed and are consistently associated with reduced activation of the dorsolateral prefrontal cortex (dlPFC). Deficits in those functions have been shown to be closely related to negative symptoms, thought disorder, and functional outcome in schizophrenia leading to the notion that frontal lobe dysfunction is crucially important in schizophrenic psychopathology.
Read more
Noninvasive brain stimulation like tDCS can enhance executive functions like working memory in healthy subjects as well as in patients. To identify the optimal parameters for this intervention in patients with schizophrenia, the investigators first test the effects of different polarities (anodal, cathodal), stimulation intensities (1mA, 2mA) and laterality (left, right) on working-memory performance (nback task) in a sham-controlled cross-over design (n=128). To elucidate mechanisms of action, oscillatory brain activity will be registered with electroencephalography (EEG).
These experiments will provide reliable data for an evidence-based development of new clinical interventions to improve treatment of cognitive deficits in patients with schizophrenia and thus enhance schizophrenia prevention and recovery.
Read the detailed description
- Working hypothesis: In patients with subacute schizophrenia, transcranial direct current stimulation (tDCS) to the dorsolateral prefrontal cortex (dlPFC) exerts lasting beneficial effects on working-memory performance.
- Research question(s): In patients with remitted early phase schizophrenia, this research project aims at providing evidence for:
- immediate improvement of working-memory performance by application of tDCS to the dlPFC in patients with schizophrenia; ii) determination of the optimal stimulation polarity, dosage and localization; iii) neurophysiological mechanisms (modulation in oscillatory activity and functional connectivity) and predictors of tDCS effects; iv) modulating effect of gender on the malleability of executive functions with tDCS.
- Previous work of the investigators: The investigators have provided proof-of principle evidence for persisting improvement of cognitive planning by a polarity-specific learning-stage dependent coupling of training and stimulation. The investigators have demonstrated that working memory and deficient cognitive control can be enhanced with anodal tDCS in depression and that the effects of tDCS are modulated by genetic polymorphisms. The investigators were the first to show impaired cortical plasticity following tDCS in schizophrenia patients at different disease states. Finally, the investigators have just successfully finished the world-wide largest clinical trial investigating the efficacy of non-invasive brain stimulation (rTMS) on negative symptoms in schizophrenia (DFG 241/10-1, Falkai, Hasan).
- Aims and work plan:
To examine the potential of tDCS for the improvement of working memory with remitted schizophrenia the investigators are following this work plan:
- Immediate effects on performance:
Assessment of efficacy of tDCS polarity (anodal, cathodal), dosage (1mA, 2mA) and laterality (left and right dlPFC) on working memory (adaptive n-back(6)) in patients (n=2x2x2x16=128). In a two-session cross-over design, stimulation (tDCS and sham) will be applied to the dlPFC (left or right) for 20min (during task performance).
- Conditions
- Anodal Stimulation tDCS, Schizophrenia, Working Memory
- Being tested
- Transcranial direct current 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
Also called tDCS
| Study group | Role | What they receive |
|---|---|---|
| Transcranial direct current stimulation | Active comparator | tDCS with varying intensity, location and polarity Receives: Procedure: Transcranial direct current stimulation |
| Sham stimulation | Placebo comparator | Double blind sham stimulation with sham mode of neuroConn device Receives: Procedure: Transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of dprime
dprime provides the separation between the means of the signal and the noise distributions, compared against the standard deviation of the signal plus noise distributions
Measured: Assessment during stimulation in a n-back task at three specific timepoints during one week
Secondary outcomes (1)
Change of reaction time in n-back task
Measured: Assessment during stimulation in a n-back task at three specific timepoints during one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2016 (estimated)
- Study startOct 2015
- Primary completionAug 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anodal Stimulation tDCSStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Munich
- Responsible party
- Principal investigator, Christian Plewnia, MD, University Hospital Tuebingen
- Investigators
- Christian Plewnia, Prof., MD, Principal investigator, University Hospital Tuebingen, Department of Psychiatry and Psychotherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02823639
- Sponsor's protocol ID
- 01EE1407H
- Status last verified
- Apr 2021
- First submitted
- 20 Jun 2016
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Mechanisms of Transcranial Direct Current Stimulation (tDCS) - Effects on Working Memory in Schizophrenia
- ClinicalTrials.gov ID
- NCT02823639
- Acronym / sponsor ID
- 01EE1407H
- Conditions
- Anodal Stimulation tDCS, Schizophrenia, Working Memory
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- University Hospital Munich
- Study start
- Oct 2015
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 6 Jul 2016 (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.
Impairments of cognition are a core, severely disabling feature of schizophrenia leading to poor long-term outcome with no established treatment available.
Particularly impaired executive functions (e.g working memory) are frequently observed and are consistently associated with reduced activation of the dorsolateral prefrontal cortex (dlPFC). Deficits in those functions have been shown to be closely related to negative symptoms, thought disorder, and functional outcome in schizophrenia leading to the notion that frontal lobe dysfunction is crucially important in schizophrenic psychopathology.
Noninvasive brain stimulation like tDCS can enhance executive functions like working memory in healthy subjects as well as in patients. To identify the optimal parameters for this intervention in patients with schizophrenia, the investigators first test the effects of different polarities (anodal, cathodal), stimulation intensities (1mA, 2mA) and laterality (left, right) on working-memory performance (nback task) in a sham-controlled cross-over design (n=128). To elucidate mechanisms of action, oscillatory brain activity will be registered with electroencephalography (EEG).
These experiments will provide reliable data for an evidence-based development of new clinical interventions to improve treatment of cognitive deficits in patients with schizophrenia and thus enhance schizophrenia prevention and recovery.
Detailed description
- Working hypothesis: In patients with subacute schizophrenia, transcranial direct current stimulation (tDCS) to the dorsolateral prefrontal cortex (dlPFC) exerts lasting beneficial effects on working-memory performance.
- Research question(s): In patients with remitted early phase schizophrenia, this research project aims at providing evidence for:
- immediate improvement of working-memory performance by application of tDCS to the dlPFC in patients with schizophrenia; ii) determination of the optimal stimulation polarity, dosage and localization; iii) neurophysiological mechanisms (modulation in oscillatory activity and functional connectivity) and predictors of tDCS effects; iv) modulating effect of gender on the malleability of executive functions with tDCS.
- Previous work of the investigators: The investigators have provided proof-of principle evidence for persisting improvement of cognitive planning by a polarity-specific learning-stage dependent coupling of training and stimulation. The investigators have demonstrated that working memory and deficient cognitive control can be enhanced with anodal tDCS in depression and that the effects of tDCS are modulated by genetic polymorphisms. The investigators were the first to show impaired cortical plasticity following tDCS in schizophrenia patients at different disease states. Finally, the investigators have just successfully finished the world-wide largest clinical trial investigating the efficacy of non-invasive brain stimulation (rTMS) on negative symptoms in schizophrenia (DFG 241/10-1, Falkai, Hasan).
- Aims and work plan:
To examine the potential of tDCS for the improvement of working memory with remitted schizophrenia the investigators are following this work plan:
- Immediate effects on performance:
Assessment of efficacy of tDCS polarity (anodal, cathodal), dosage (1mA, 2mA) and laterality (left and right dlPFC) on working memory (adaptive n-back(6)) in patients (n=2x2x2x16=128). In a two-session cross-over design, stimulation (tDCS and sham) will be applied to the dlPFC (left or right) for 20min (during task performance).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcranial direct current stimulation | Active comparator | Procedure: Transcranial direct current stimulationtDCS with varying intensity, location and polarity |
| Sham stimulation | Placebo comparator | Procedure: Transcranial direct current stimulationDouble blind sham stimulation with sham mode of neuroConn device |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- diagnosed schizophrenia (DSM-V)
- age (18 - 60 years)
- right handedness
- stable medication during 1 week of treatment and 1 week before
Key exclusion criteria (6 listed)
- history of seizures
- metal device throughout the body
- pregnancy
- use of anticonvulsive medication
- use of benzodiazepines more than 1 mg of Lorazepam equivalent
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 stimulationAlso: tDCS | Procedure or surgery | Sham stimulation, Transcranial direct current stimulation |
Primary outcome
Change of dprime
Time frame: Assessment during stimulation in a n-back task at three specific timepoints during one week
dprime provides the separation between the means of the signal and the noise distributions, compared against the standard deviation of the signal plus noise distributions
1 secondary outcome
Change of reaction time in n-back task
Time frame: Assessment during stimulation in a n-back task at three specific timepoints during one week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Individual participant dataSharing planned: Undecided
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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.
Christian Plewnia, Prof., MD principal investigator
University Hospital Tuebingen, Department of Psychiatry and Psychotherapy
2 sites 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 Anodal Stimulation tDCS and Schizophrenia, run by University Hospital Tuebingen at 2 sites 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christian Plewnia, MD (++49 (0)7071-2986121, christian.plewnia@uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of dprime (time frame: Assessment during stimulation in a n-back task at three specific timepoints during one 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 28 Apr 2021.