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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| anodal tDCS, then sham tDCS | Experimental | 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. |
|
| sham tDCS, then anodal tDCS | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcranial direct current stimulation | Device | Soterix 1x1 anodal tDCS |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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:
Pregnancy in women, as determined by self-report
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Feinstein Institute for Medical Research | Manhasset | New York | 11030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18096677 | Background | 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. | |
| 20395612 | Background | 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. |
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All participants received both the active and sham tDCS conditions, and sequence of stimulation conditions was randomized across participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | Anodal tDCS, Then Sham tDCS | Participants first received 1 single 20 min session of anodal tDCS + computerized naming therapy. After a washout period of 1 week, they then received 1 single 20 min session of sham tDCS + computerized naming therapy. |
| FG001 | Sham tDCS, Then Anodal tDCS | Participants first received 1 single 20 min session of sham tDCS + computerized naming therapy. After a washout period of 1 week, they then received 1 single 20 min session of anodal tDCS + computerized naming therapy. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Crossover design study: All participants were randomized to receive one single 20 min session of anodal tDCS and 1 single session of sham tDCS followed by computerized naming therapy. Sequence of stimulation conditions was counterbalanced across participants with a 1 week washout period in between conditions. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | All participants received one dose of each intervention and completed all study visits. They were consequently all included in the efficacy analysis. | Posted | Mean | Standard Deviation | score | baseline, discharge |
|
Two weeks for each intervention
Safety population included all participants who received at least one dose of intervention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Anodal tDCS | Participants who received anodal tDCS + computerized picture-naming therapy, and were followed for 2 weeks. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Johanna Chang, Senior Research Coordinator | Northwell Health | (516)562-3646 | jchang14@northwell.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 27, 2016 | Mar 8, 2018 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 25, 2016 | Mar 8, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D001037 | Aphasia |
| D001072 | Apraxias |
| D003147 | Communication Disorders |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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All participants received both stimulation conditions (active tDCS + computerized naming therapy and sham tDCS + computerized naming therapy), separated by a 1-week washout period.
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Sequence of stimulation conditions was randomized across subjects.
| 20946060 | Background | 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. |
| 23060684 | Background | 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. |
| 24333381 | Background | 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. |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Sham tDCS | Participants who received sham tDCS + computerized picture-naming therapy, and were followed for 2 weeks. | 0 | 15 | 0 | 15 | 0 | 15 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013064 | Speech Disorders |
| D007806 | Language Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011596 | Psychomotor Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |