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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Charite University, Berlin, Germany
Sponsor:
Information provided by (Responsible Party):
Agnes Flöel, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01865578
First received: May 21, 2013
Last updated: February 13, 2014
Last verified: February 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Resource links provided by NLM:


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

Primary Outcome Measures:
  • neurophysiological measurements using TMS [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    performance in a motor task is compared after a tDCS or sham stimulation


Estimated Enrollment: 40
Study Start Date: April 2012
Estimated Primary Completion Date: December 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01865578

Contacts
Contact: Harald Pruess, MD 0049 30 450 560 075 harald.pruess@charite.de

Locations
Germany
Charite University Medicine Recruiting
Berlin, Germany, 10098
Contact: Magdalena S Volz, MD       magdalena.volz@charite.de   
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Principal Investigator: Agnes Floeel, Prof. MD Charite University
  More Information

No publications provided

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
Study First Received: May 21, 2013
Last Updated: February 13, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Encephalitis
Anti-N-Methyl-D-Aspartate Receptor Encephalitis
Central Nervous System Viral Diseases
Virus Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Infections
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

ClinicalTrials.gov processed this record on September 15, 2014