Anti-NMDA Receptor EncephalitisNCT01865578
Transcranial Direct Current Stimulation on Cortical Plasticity in Patients With Anti-NMDA Receptor Encephalitis
A study testing tDCS in people with Anti-NMDA Receptor Encephalitis, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
Patients suffering from anti-NMDA receptor encephalitis show impaired NMDA-receptor dependent neuronal transmission. Furthermore, they often have cognitive deficits of different magnitude. Impaired neuronal signaling of NMDA-receptors very likely result in decreased cortical synaptic plasticity. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anti-NMDA Receptor Encephalitis
- What is being tested?
- tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2012to May 2015
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients suffering from anti-NMDA receptor encephalitis
- healthy (control) subjects
Who cannot join
- Any metal inside the body/head, e.g. clips, pace maker, medical pumps, cochlear implant etc.
- Traumatic brain injury
- Stroke
- Cerebral tumor
- Pregnancy
- untreated severe internal or psychiatric diseases
Trial locations and contacts
1 site in 1 country.
About this study
Patients suffering from anti-NMDA receptor encephalitis show impaired NMDA-receptor dependent neuronal transmission. Furthermore, they often have cognitive deficits of different magnitude. Impaired neuronal signaling of NMDA-receptors very likely result in decreased cortical synaptic plasticity. Thus, this represents one major reason of cognitive deficits. Synaptic plasticity can be assessed in humans via the non-invasive technique of transcranial magnetic stimulation (TMS).
The current study aims to investigate whether learning ability and also cortical plasticity can be changed by applying sessions of transcranial direct current stimulation (tDCS). Therefore, we are recruiting 10 to 15 patients suffering from anti-NMDA receptor encephalitis as well as healthy controls in order to compare tDCS effects. Learning ability is assessed by motor sequence tasks, whereas cortical plasticity is measured via TMS.
Read more
tDCS is a novel non-invasive technique allowing induction of changes in cerebral excitability level and also cortical plasticity. Previous studies showed positive outcome of anodal stimulation on learning tasks. Especially motor learning seems to be an important target for tDCS treatment since it showed best results for both post-stroke patients and healthy subjects. Multiple sessions of tDCS are inducing long-term effects and improved learning function, which were present three months after stimulation.
In this study we hope to reveals new insights into the pathomechanisms of impaired cognitive and learning abilities in patients having anti-NMDA receptor encephalitis. Moreover, we evaluate whether tDCS is an effective treatment for patients with cognitive and learning deficits.
- Conditions
- Anti-NMDA Receptor Encephalitis
- Being tested
- tDCS, Sham Stimulation
- Medical subject headings
- Anti-N-Methyl-D-Aspartate Receptor Encephalitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
Transcranial direct current stimulation involves the application of weak electric currents to the brain.
Sham StimulationDevice
no electrical stimulation
| Study group | Role | What they receive |
|---|---|---|
| tDCS | Experimental | Transcranial direct current stimulation Receives: Device: tDCS |
| sham stimulation | Sham comparator | sham stimulation Receives: Device: Sham Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
neurophysiological measurements using TMS
TMS protocoll (a paired associative stimulation) is applied after tDCS or sham stimulation
Measured: 1 week
Secondary outcomes (1)
performance in a motor task
performance in a motor task is compared after a tDCS or sham stimulation
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 posted31 May 2013 (estimated)
- Study startApr 2012
- Primary completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anti-NMDA Receptor EncephalitisStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agnes Flöel, Charite University, Berlin, Germany
- Investigators
- Agnes Floeel, Prof. MD, Principal investigator, Charite University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01865578
- Sponsor's protocol ID
- EA1/037/12
- Status last verified
- Mar 2016
- First submitted
- 21 May 2013
- Last updated
- 17 Mar 2016
- Results posted
- No
Publications
Volz MS, Finke C, Harms L, Jurek B, Paul F, Floel A, Pruss H. Altered paired associative stimulation-induced plasticity in NMDAR encephalitis. Ann Clin Transl Neurol. 2016 Jan 16;3(2):101-13. doi: 10.1002/acn3.277. eCollection 2016 Feb.
PubMed 26900584
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation on Cortical Plasticity in Patients With Anti-NMDA Receptor Encephalitis
- ClinicalTrials.gov ID
- NCT01865578
- Acronym / sponsor ID
- EA1/037/12
- Conditions
- Anti-NMDA Receptor Encephalitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- May 2015 (actual)
- First posted
- 31 May 2013 (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.
Patients suffering from anti-NMDA receptor encephalitis show impaired NMDA-receptor dependent neuronal transmission. Furthermore, they often have cognitive deficits of different magnitude. Impaired neuronal signaling of NMDA-receptors very likely result in decreased cortical synaptic plasticity. Thus, this represents one major reason of cognitive deficits. Synaptic plasticity can be assessed in humans via the non-invasive technique of transcranial magnetic stimulation (TMS).
The current study aims to investigate whether learning ability and also cortical plasticity can be changed by applying sessions of transcranial direct current stimulation (tDCS). Therefore, we are recruiting 10 to 15 patients suffering from anti-NMDA receptor encephalitis as well as healthy controls in order to compare tDCS effects. Learning ability is assessed by motor sequence tasks, whereas cortical plasticity is measured via TMS.
tDCS is a novel non-invasive technique allowing induction of changes in cerebral excitability level and also cortical plasticity. Previous studies showed positive outcome of anodal stimulation on learning tasks. Especially motor learning seems to be an important target for tDCS treatment since it showed best results for both post-stroke patients and healthy subjects. Multiple sessions of tDCS are inducing long-term effects and improved learning function, which were present three months after stimulation.
In this study we hope to reveals new insights into the pathomechanisms of impaired cognitive and learning abilities in patients having anti-NMDA receptor encephalitis. Moreover, we evaluate whether tDCS is an effective treatment for patients with cognitive and learning deficits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tDCS | Experimental | Device: tDCSTranscranial direct current stimulation |
| sham stimulation | Sham comparator | Device: Sham Stimulationsham stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients suffering from anti-NMDA receptor encephalitis
- healthy (control) subjects
Key exclusion criteria (6 listed)
- Any metal inside the body/head, e.g. clips, pace maker, medical pumps, cochlear implant etc.
- Traumatic brain injury
- Stroke
- Cerebral tumor
- Pregnancy
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 |
|---|---|---|
| tDCSTranscranial direct current stimulation involves the application of weak electric currents to the brain. | Device | tDCS |
| Sham Stimulationno electrical stimulation | Device | sham stimulation |
Primary outcome
neurophysiological measurements using TMS
Time frame: 1 week
TMS protocoll (a paired associative stimulation) is applied after tDCS or sham stimulation
1 secondary outcome
performance in a motor task
Time frame: 1 week
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 17 Mar 2016.
- Derived from this study: PubMed 26900584Volz MS, Finke C, Harms L, Jurek B, Paul F, Floel A, Pruss H. Altered paired associative stimulation-induced plasticity in NMDAR encephalitis. Ann Clin Transl Neurol. 2016 Jan 16;3(2):101-13. doi: 10.1002/acn3.277. eCollection 2016 Feb.
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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.
Agnes Floeel, Prof. MD principal investigator
Charite 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 tDCS in people with Anti-NMDA Receptor Encephalitis, run by Charite University, Berlin, Germany 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 2 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: finished, as of the sponsor's last update on 17 Mar 2016. 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?
neurophysiological measurements using TMS (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01865578, which also lists 1 linked publication.
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 17 Mar 2016.