Evaluating Anodal tDCS Preceding Aphasia Therapy

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2017-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Stroke Aphasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Sequence of stimulation conditions was randomized across subjects.

Study Groups

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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.

Group Type EXPERIMENTAL

transcranial direct current stimulation

Intervention Type DEVICE

Soterix 1x1 anodal tDCS

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.

Group Type EXPERIMENTAL

transcranial direct current stimulation

Intervention Type DEVICE

Soterix 1x1 anodal tDCS

Interventions

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transcranial direct current stimulation

Soterix 1x1 anodal tDCS

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No