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Transcranial Direct Current Stimulation on Cortical Plasticity in Patients With Anti-NMDA Receptor Encephalitis

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ClinicalTrials.gov Identifier: NCT01865578
Recruitment Status : Completed
First Posted : May 31, 2013
Last Update Posted : March 17, 2016
Sponsor:
Information provided by (Responsible Party):
Agnes Flöel, Charite University, Berlin, Germany

Tracking Information
First Submitted Date  ICMJE May 21, 2013
First Posted Date  ICMJE May 31, 2013
Last Update Posted Date March 17, 2016
Study Start Date  ICMJE April 2012
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 28, 2013)
neurophysiological measurements using TMS [ Time Frame: 1 week ]
TMS protocoll (a paired associative stimulation) is applied after tDCS or sham stimulation
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01865578 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 28, 2013)
performance in a motor task [ Time Frame: 1 week ]
performance in a motor task is compared after a tDCS or sham stimulation
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Transcranial Direct Current Stimulation on Cortical Plasticity in Patients With Anti-NMDA Receptor Encephalitis
Official Title  ICMJE Not Provided
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Anti-NMDA Receptor Encephalitis
Intervention  ICMJE
  • Device: tDCS
    Transcranial direct current stimulation involves the application of weak electric currents to the brain.
  • Device: Sham Stimulation
    no electrical stimulation
Study Arms  ICMJE
  • Experimental: tDCS
    Transcranial direct current stimulation
    Intervention: Device: tDCS
  • Sham Comparator: sham stimulation
    sham stimulation
    Intervention: Device: Sham Stimulation
Publications * Volz MS, Finke C, Harms L, Jurek B, Paul F, Flöel A, Prüss 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: May 28, 2013)
40
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01865578
Other Study ID Numbers  ICMJE EA1/037/12
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Agnes Flöel, Charite University, Berlin, Germany
Study Sponsor  ICMJE Charite University, Berlin, Germany
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Agnes Floeel, Prof. MD Charite University
PRS Account Charite University, Berlin, Germany
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP