N/A
N=28
Cerebellar Transcranial Direct Current Stimulation and Aphasia Treatment
Stroke
Bottom Line
View on ClinicalTrials.gov: NCT02901574 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Apr 2023
Primary outcome: Primary: Change in Accuracy of Naming Untrained Pictures (Philadelphia Naming Test:PNT) Pre-treatment to Post-treatment — 5.76; 1.88 score on a scale — p=0.24
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Anodal or Cathodal tDCS (Device); Sham (Device); Computerized naming therapy (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Accuracy of Naming Untrained Pictures (Philadelphia Naming Test:PNT) Pre-treatment to Post-treatment |
5.76; 1.88 | 0.24 |
| SECONDARY Change in Accuracy of Naming Untrained Pictures (Philadelphia Naming Test:PNT)Pre-treatment to 2 Weeks Post-treatment. |
8.31; 1.18 | — |
| SECONDARY Change in Accuracy of Naming Untrained Pictures (Philadelphia Naming Test:PNT) Pre-treatment to 2 Months Post-treatment. |
9.03; 0.38 | — |
| SECONDARY Change in Functional Communication Skills on the ASHA-FACS Communication Independence Scale Pre-treatment to Post-treatment |
0.27; 0.11 | — |
| SECONDARY Change in Functional Communication Skills on the ASHA-FACS Communication Independence Scale Pre-treatment to 2 Weeks Post-treatment |
0.28; 0.35 | — |
| SECONDARY Change in Functional Communication Skills on the ASHA-FACS Communication Independence Scale Pre-treatment to 2 Months Post-treatment |
0.278; 0.251 | — |
| SECONDARY Change in Functional Communication Skills on the ASHA-FACS Qualitative Dimensions of Communication Scale Pre-treatment to Post-treatment |
0.33; 0.04 | — |
| SECONDARY Change in Functional Communication Skills on the ASHA-FACS Qualitative Dimensions of Communication Scale Pre-Treatment to 2 Week Post-Treatment |
0.329; 0.047 | — |
| SECONDARY Change in Functional Communication Skills on the ASHA-FACS Qualitative Dimensions of Communication Scale Pre-treatment to 2 Months Post-treatment |
0.351; 0.044 | — |
| SECONDARY Change in Discourse Ability Pre-treatment to Post-treatment. |
1.28; -1.03 | — |
| SECONDARY Change in Discourse Ability Pre- Treatment to 2 Weeks Post-treatment. |
0.52; -2.119 | — |
| SECONDARY Change in Discourse Ability Pre-treatment to 2 Months Post-treatment. |
1.63; 0.36 | — |
Summary
People with post-stroke aphasia are left with some degree of chronic deficit for which current rehabilitative treatments are variably effective. This study investigates the behavioral and neural effects of multiple consecutive cerebellar tDCS sessions coupled with computerized naming therapy in stroke survivors with aphasia.
Eligibility Criteria
Inclusion Criteria
- Participants must have sustained a left hemisphere stroke.
- Participants must be fluent speakers of English by self-report.
- Participants must be capable of giving informed consent or indicating another to provide informed consent.
- Participants must be age 18 or older.
- Participants must be premorbidly right handed.
- Participants must be at least 6 months post stroke.
- Participants must have an aphasia diagnosis as confirmed by the Boston Diagnostic Aphasia Examination (BDAE) Short Form.
- Participants must achieve at least 65% accuracy on screening task (comparable to treatment task) on 1 of 3 attempts
Exclusion Criteria
- Participants with lesion involving the right cerebellum
- Previous neurological or psychiatric disease.
- Seizures during the previous 12 months.
- Uncorrected visual loss or hearing loss by self-report.
- Use of medications that lower the seizure threshold (e.g., methylphenidate, amphetamine salts).
- Use of N-methyl-D-aspartate receptor (NMDA) antagonists (e.g., memantine).
- > 80% (140 out of 175) correct responses on the Philadelphia Naming Test at baseline.
- History of brain surgery or any metal in the head.
- Scalp sensitivity (per participant report).
Data sourced from ClinicalTrials.gov (NCT02901574). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.