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

Anti-NMDA Receptor Encephalitis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01865578
• Other study ID #: EA1/037/12
• Status: Completed
• Phase: N/A
• First received: May 21, 2013
• Last updated: March 16, 2016
• Start date: April 2012

Study information

• Verified date: March 2016
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anti-N-Methyl-D-Aspartate Receptor Encephalitis
• Anti-NMDA Receptor Encephalitis
• Encephalitis

Intervention

Device:
• tDCS
Transcranial direct current stimulation involves the application of weak electric currents to the brain.
• Sham Stimulation
no electrical stimulation

Locations

Country	Name	City	State
Germany	Charite University Medicine	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	neurophysiological measurements using TMS	TMS protocoll (a paired associative stimulation) is applied after tDCS or sham stimulation	1 week	No
Secondary	performance in a motor task	performance in a motor task is compared after a tDCS or sham stimulation	1 week	No