Clinical trial NCT02249819: Evaluating Anodal tDCS Preceding Aphasia Therapy
Official title: Evaluating Anodal tDCS Preceding Aphasia Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Stroke
Aphasia
Keywords: stroke
aphasia
CVA
apraxia
cerebrovascular accident
cerebral stroke
speech therapy
aphasia therapy
non-invasive brain stimulation
transcranial direct current stimulation
tDCS
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2014-09-26
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: All participants received both stimulation conditions (active tDCS + computerized naming therapy and sham tDCS + computerized naming therapy), separated by a 1-week washout period.
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean Change in Picture-naming Accuracy Score
timeFrame: baseline, discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Manhasset
country: United States
facility: Feinstein Institute for Medical Research
state: New York
Study officials:
References:
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. doi: 10.1136/jnnp.2007.135277. Epub 2007 Dec 20.
citation: 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.
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.
citation: Holland R, Crinion J. Can tDCS enhance treatment of aphasia after stroke? Aphasiology. 2012 Sep;26(9):1169-1191. doi: 10.1080/02687038.2011.616925. Epub 2011 Nov 3.
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.