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

Primary Purpose

Anti-NMDA Receptor Encephalitis

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
tDCS
Sham Stimulation
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anti-NMDA Receptor Encephalitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Charite University Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

tDCS

sham stimulation

Arm Description

Transcranial direct current stimulation

sham stimulation

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

performance in a motor task
performance in a motor task is compared after a tDCS or sham stimulation

Full Information

First Posted
May 21, 2013
Last Updated
March 16, 2016
Sponsor
Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT01865578
Brief Title
Transcranial Direct Current Stimulation on Cortical Plasticity in Patients With Anti-NMDA Receptor Encephalitis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anti-NMDA Receptor Encephalitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
tDCS
Arm Type
Experimental
Arm Description
Transcranial direct current stimulation
Arm Title
sham stimulation
Arm Type
Sham Comparator
Arm Description
sham stimulation
Intervention Type
Device
Intervention Name(s)
tDCS
Intervention Description
Transcranial direct current stimulation involves the application of weak electric currents to the brain.
Intervention Type
Device
Intervention Name(s)
Sham Stimulation
Intervention Description
no electrical stimulation
Primary Outcome Measure Information:
Title
neurophysiological measurements using TMS
Description
TMS protocoll (a paired associative stimulation) is applied after tDCS or sham stimulation
Time Frame
1 week
Secondary Outcome Measure Information:
Title
performance in a motor task
Description
performance in a motor task is compared after a tDCS or sham stimulation
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Agnes Floeel, Prof. MD
Organizational Affiliation
Charite University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charite University Medicine
City
Berlin
ZIP/Postal Code
10098
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
26900584
Citation
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.
Results Reference
derived

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

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