Evaluating Anodal tDCS Preceding Aphasia Therapy

Stroke Clinical Trial

Official title:

Evaluating Anodal tDCS Preceding Aphasia Therapy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02249819
• Other study ID #: 14-416
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: September 2014
• Est. completion date: November 2017

Study information

• Verified date: February 2019
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if non-invasive brain stimulation (transcranial direct current stimulation) delivered prior to language therapy will improve word-finding in individuals with aphasia who are 6 months or greater post-stroke.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: November 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. = 18 years of age

2. First single focal unilateral left hemisphere lesion with diagnosis verified by brain imaging (MRI or CT scans) that occurred at least 6 months prior

3. Pre-morbidly right handed

4. Pre-morbidly fluent English speaker

5. Cognitive function sufficient to understand the experiments and follow instructions (per interview with Speech Pathologist)

6. A baseline Aphasia Quotient score between 10 to 94 out of 100 points on the Western Aphasia Battery (neither completely without language comprehension/expression nor fully recovered from aphasia).

Exclusion Criteria:

1. Ongoing use of CNS-active medications

2. Ongoing use of psychoactive medications, such as stimulants, antidepressants, and anti-psychotic medications

3. Presence of additional potential tDCS risk factors:

• Damaged skin at the site of stimulation (i.e., skin with ingrown hairs, acne, razor nicks, wounds that have not healed, recent scar tissue, broken skin, etc.)
• Presence of an electrically, magnetically or mechanically activated implant (including cardiac pacemaker), an intracerebral vascular clip, or any other electrically sensitive support system
• Metal in any part of the body, including metal injury to the eye (jewelry must be removed during stimulation)
• A history of medication-resistant epilepsy in the family
• Past history of seizures or unexplained spells of loss of consciousness during the previous 36 months

4. Pregnancy in women, as determined by self-report

Related Conditions & MeSH terms

• Aphasia
• Stroke

Intervention

Device:
• transcranial direct current stimulation
Soterix 1x1 anodal tDCS

Locations

Country	Name	City	State
United States	Feinstein Institute for Medical Research	Manhasset	New York

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

References & Publications (5)

Baker JM, Rorden C, Fridriksson J. Using transcranial direct-current stimulation to treat stroke patients with aphasia. Stroke. 2010 Jun;41(6):1229-36. doi: 10.1161/STROKEAHA.109.576785. Epub 2010 Apr 15. — View Citation

Fiori V, Coccia M, Marinelli CV, Vecchi V, Bonifazi S, Ceravolo MG, Provinciali L, Tomaiuolo F, Marangolo P. Transcranial direct current stimulation improves word retrieval in healthy and nonfluent aphasic subjects. J Cogn Neurosci. 2011 Sep;23(9):2309-23. doi: 10.1162/jocn.2010.21579. Epub 2010 Oct 14. — View Citation

Holland R, Crinion J. Can tDCS enhance treatment of aphasia after stroke? Aphasiology. 2012 Sep;26(9):1169-1191. Epub 2011 Nov 3. — View Citation

Marangolo P, Fiori V, Campana S, Calpagnano MA, Razzano C, Caltagirone C, Marini A. Something to talk about: enhancement of linguistic cohesion through tdCS in chronic non fluent aphasia. Neuropsychologia. 2014 Jan;53:246-56. doi: 10.1016/j.neuropsychologia.2013.12.003. Epub 2013 Dec 11. — View Citation

Monti A, Cogiamanian F, Marceglia S, Ferrucci R, Mameli F, Mrakic-Sposta S, Vergari M, Zago S, Priori A. Improved naming after transcranial direct current stimulation in aphasia. J Neurol Neurosurg Psychiatry. 2008 Apr;79(4):451-3. Epub 2007 Dec 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change in Picture-naming Accuracy Score	The mean change in verbal picture-naming accuracy score (out of 75) was calculated from baseline to discharge in each condition (sham and active tDCS).	baseline, discharge