Evaluating Anodal tDCS Preceding Aphasia Therapy
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Sponsor
- Northwell Health
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Mean Change in Picture-naming Accuracy Score
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Sequence of stimulation conditions was randomized across subjects.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •≥ 18 years of age
- •First single focal unilateral left hemisphere lesion with diagnosis verified by brain imaging (MRI or CT scans) that occurred at least 6 months prior
- •Pre-morbidly right handed
- •Pre-morbidly fluent English speaker
- •Cognitive function sufficient to understand the experiments and follow instructions (per interview with Speech Pathologist)
- •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
- •Ongoing use of CNS-active medications
- •Ongoing use of psychoactive medications, such as stimulants, antidepressants, and anti-psychotic medications
- •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
- •Pregnancy in women, as determined by self-report
Arms & Interventions
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.
Intervention: transcranial direct current stimulation (Device)
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.
Intervention: transcranial direct current stimulation (Device)
Outcomes
Primary Outcomes
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).
Secondary Outcomes
No secondary outcomes reported
Investigators
Bruce Volpe
Principal Investigator
Northwell Health