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TDCS in Acute Stroke (TDCS-aphasia)

Charité University Medicine Berlin logo

Charité University Medicine Berlin

Status

Unknown

Conditions

Stroke

Treatments

Device: Sham-TDCS
Device: DKI ED2011

Study type

Interventional

Funder types

Other

Identifiers

NCT01701713
EA4/109/08 (Other Identifier)
TDCS_CSB-Brandenburg

Details and patient eligibility

About

The purpose of this study is to determine the safety of transcranial direct current stimulation in aphasia therapy in acute and post-acute stroke.

Full description

TDCS has been shown to have a positive effect on clinical outcome in both motor rehabilitation and aphasia treatment in chronic aphasic patients. In healthy subjects the method sped up reaction times in naming and language learning tasks. In TDCS a weak current is applied to the subjects head increasing excitatory activity which might lead to improved brain function.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • first media stroke
  • language impairment
  • informed consent
  • right handedness
  • NIHSS < 20

Exclusion criteria

  • previous Epilepsy oder epileptogenic events
  • epilepsy typical elements in EEG
  • hypersensitive skin (head)
  • metal implants (head)
  • pace maker or other electronic implants
  • previous head/brain surgery
  • medication reducing seizure threshold
  • previous psychiatric events

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

100 participants in 2 patient groups

TDCS - DKI ED2011
Experimental group
Description:
TDCS with DKI ED2011 session is followed by a behavioral naming therapy with different cues
Treatment:
Device: DKI ED2011
Sham-TDCS
Sham Comparator group
Description:
Sham-TDCS session is followed by a behavioral naming therapy with different cues
Treatment:
Device: Sham-TDCS

Trial contacts and locations

2

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Central trial contact

Isabell Wartenburger, Prof. MD; Gerhard J Jungehuelsing, MD

Data sourced from clinicaltrials.gov

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