NCT01865578

Brief 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. 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 21, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 31, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Last Updated

March 17, 2016

Status Verified

March 1, 2016

Enrollment Period

3.1 years

First QC Date

May 21, 2013

Last Update Submit

March 16, 2016

Conditions

Anti-NMDA Receptor Encephalitis

Outcome Measures

Primary Outcomes (1)

  • neurophysiological measurements using TMS

    TMS protocoll (a paired associative stimulation) is applied after tDCS or sham stimulation

    1 week

Secondary Outcomes (1)

  • performance in a motor task

    1 week

Study Arms (2)

tDCS

EXPERIMENTAL

Transcranial direct current stimulation

Device: tDCS

sham stimulation

SHAM COMPARATOR

sham stimulation

Device: Sham Stimulation

Interventions

tDCSDEVICE

Transcranial direct current stimulation involves the application of weak electric currents to the brain.

tDCS
Sham StimulationDEVICE

no electrical stimulation

sham stimulation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients suffering from anti-NMDA receptor encephalitis
  • healthy (control) subjects

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charite University Medicine

Berlin, State of Berlin, 10098, Germany

Location

Related Publications (1)

  • 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.

    PMID: 26900584DERIVED

MeSH Terms

Conditions

Anti-N-Methyl-D-Aspartate Receptor Encephalitis

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Paraneoplastic Syndromes, Nervous SystemNervous System NeoplasmsNeoplasms by SiteNeoplasmsParaneoplastic SyndromesEncephalitisBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurodegenerative DiseasesNeuroinflammatory DiseasesAutoimmune Diseases of the Nervous SystemAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Agnes Floeel, Prof. MD

    Charite University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med Agnes Floeel

Study Record Dates

First Submitted

May 21, 2013

First Posted

May 31, 2013

Study Start

April 1, 2012

Primary Completion

May 1, 2015

Last Updated

March 17, 2016

Record last verified: 2016-03

Locations

DE(1)