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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01865578
First Posted: May 31, 2013
Last Update Posted: March 17, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Agnes Flöel, Charite University, Berlin, Germany
  Purpose

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.


Condition Intervention
Anti-NMDA Receptor Encephalitis Device: tDCS Device: Sham Stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Agnes Flöel, Charite University, Berlin, Germany:

Primary Outcome Measures:
  • neurophysiological measurements using TMS [ Time Frame: 1 week ]
    TMS protocoll (a paired associative stimulation) is applied after tDCS or sham stimulation


Secondary Outcome Measures:
  • performance in a motor task [ Time Frame: 1 week ]
    performance in a motor task is compared after a tDCS or sham stimulation


Estimated Enrollment: 40
Study Start Date: April 2012
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: tDCS
Transcranial direct current stimulation
Device: tDCS
Transcranial direct current stimulation involves the application of weak electric currents to the brain.
Sham Comparator: sham stimulation
sham stimulation
Device: Sham Stimulation
no electrical stimulation

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01865578


Locations
Germany
Charite University Medicine
Berlin, Germany, 10098
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Principal Investigator: Agnes Floeel, Prof. MD Charite University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Agnes Flöel, Prof. Dr. med Agnes Floeel, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01865578     History of Changes
Other Study ID Numbers: EA1/037/12
First Submitted: May 21, 2013
First Posted: May 31, 2013
Last Update Posted: March 17, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
Encephalitis
Anti-N-Methyl-D-Aspartate Receptor Encephalitis
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Paraneoplastic Syndromes, Nervous System
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Paraneoplastic Syndromes
Neurodegenerative Diseases
Autoimmune Diseases of the Nervous System
Autoimmune Diseases
Immune System Diseases