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

March 16, 2016 updated by: Agnes Flöel, Charite University, Berlin, Germany

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10098
        • Charité University Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Device: Sham Stimulation
no electrical stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
neurophysiological measurements using TMS
Time Frame: 1 week
TMS protocoll (a paired associative stimulation) is applied after tDCS or sham stimulation
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
performance in a motor task
Time Frame: 1 week
performance in a motor task is compared after a tDCS or sham stimulation
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Investigators

  • Principal Investigator: Agnes Floeel, Prof. MD, Charité University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

May 21, 2013

First Submitted That Met QC Criteria

May 28, 2013

First Posted (Estimate)

May 31, 2013

Study Record Updates

Last Update Posted (Estimate)

March 17, 2016

Last Update Submitted That Met QC Criteria

March 16, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EA1/037/12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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