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Evaluating Anodal tDCS Preceding Aphasia Therapy

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ClinicalTrials.gov Identifier: NCT02249819
Recruitment Status : Terminated
First Posted : September 26, 2014
Results First Posted : April 6, 2018
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Bruce Volpe, Northwell Health

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.

Condition or disease Intervention/treatment Phase
Stroke Aphasia Device: transcranial direct current stimulation Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Sequence of stimulation conditions was randomized across subjects.
Primary Purpose: Treatment
Official Title: Evaluating Anodal tDCS Preceding Aphasia Therapy
Actual Study Start Date : September 2014
Actual Primary Completion Date : June 2017
Actual Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aphasia

Arm Intervention/treatment
Experimental: anodal tDCS, then sham tDCS
Participants received 1 single 20 min session of anodal tDCS + computerized naming therapy. Following a 1 week washout period, they received 1 single 20 min session of sham tDCS + computerized aphasia therapy. Sequence of stimulation conditions was randomized across participants.
Device: transcranial direct current stimulation
Soterix 1x1 anodal tDCS

Experimental: sham tDCS, then anodal tDCS
Participants received 1 single 20 min session of sham tDCS + computerized naming therapy. Following a 1 week washout period, they received 1 single 20 min session of anodal tDCS + computerized aphasia therapy. Sequence of stimulation conditions was randomized across participants.
Device: transcranial direct current stimulation
Soterix 1x1 anodal tDCS




Primary Outcome Measures :
  1. Mean Change in Picture-naming Accuracy Score [ Time Frame: baseline, discharge ]
    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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02249819


Locations
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United States, New York
Feinstein Institute for Medical Research
Manhasset, New York, United States, 11030
Sponsors and Collaborators
Northwell Health
  Study Documents (Full-Text)

Documents provided by Bruce Volpe, Northwell Health:

Publications:
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Responsible Party: Bruce Volpe, Principal Investigator, Northwell Health
ClinicalTrials.gov Identifier: NCT02249819     History of Changes
Other Study ID Numbers: 14-416
First Posted: September 26, 2014    Key Record Dates
Results First Posted: April 6, 2018
Last Update Posted: February 26, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Bruce Volpe, Northwell Health:
stroke
aphasia
CVA
apraxia
cerebrovascular accident
cerebral stroke
speech therapy
aphasia therapy
non-invasive brain stimulation
transcranial direct current stimulation
tDCS

Additional relevant MeSH terms:
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Aphasia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms