N/A N=28 Randomized Quadruple-blind Treatment

Post-Stroke Aphasia and Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment Study

Aphasia · Stroke

Bottom Line

View on ClinicalTrials.gov: NCT01512264 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2019

Primary outcome: Primary: Aphasia Testing as Evaluated by the Boston Naming Test (BNT) - Baseline — 33.43; 18.29; 28.57; 41.00 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Magstim SuperRapid (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Alabama at Birmingham
Primary completion: Jul 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Aphasia Testing as Evaluated by the Boston Naming Test (BNT) - Baseline	33.43; 18.29; 28.57; 41.00	—
PRIMARY Aphasia Testing as Evaluated by the Boston Naming Test (BNT) - Immediate Follow-Up	42.43; 24.86; 30.86; 48.83	0.006 sig
PRIMARY Aphasia Testing as Evaluated by the Boston Naming Test (BNT) - Long Term Follow-up	38.50; 15.67; 25.17; 47.60	0.410
PRIMARY Aphasia Testing as Evaluated by the Semantic Fluency Test (SFT) - Baseline	16.29; 8.00; 9.57; 25.50	—
PRIMARY Aphasia Testing as Evaluated by the Semantic Fluency Test (SFT) - Immediate Follow-up	18.86; 8.86; 11.14; 29.17	0.118
PRIMARY Aphasia Testing as Evaluated by the Semantic Fluency Test (SFT) - Long Term Follow-up	19.00; 7.50; 9.83; 30.40	0.410
PRIMARY Aphasia Testing as Evaluated by the Controlled Word Association Test (COWAT) - Baseline	9.29; 4.43; 4.86; 9.33	—
PRIMARY Aphasia Testing as Evaluated by the Controlled Word Association Test (COWAT) - Immediate Follow-up	12.43; 5.43; 5.00; 10.17	0.109
PRIMARY Aphasia Testing as Evaluated by the Controlled Word Association Test (COWAT) - Long Term Follow-up	9.67; 3.33; 4.67; 12.60	0.899
PRIMARY Western Aphasia Battery (WAB) - Baseline	64.214; 54.883; 54.380; 81.740	—
PRIMARY Western Aphasia Battery (WAB) - Immediate Follow-Up	63.500; 51.520; 57.460; 77.700	0.520
PRIMARY Western Aphasia Battery (WAB) - Long-Term Follow-Up	72.417; 50.560; 61.960; 84.425	0.239
SECONDARY Change in Language Laterilazation as Indicated by Neuroimaging Correlates: Frontal Laterality Index (LI) Scores - Baseline	0.30; 0.22; -0.19; 0.13	—
SECONDARY Change in Language Lateralization as Indicated by Neuroimaging Correlates: Frontal Laterality Index (LI) Scores - Immediate Follow-up	0.02; 0.09; -0.09; -0.01	—
SECONDARY Change in Language Lateralization as Indicated by Neuroimaging Correlates: Frontal Laterality Index (LI) Scores - Long-term Follow Up	0.20; 0.20; 0.01; 0.20	—
SECONDARY Change in Language Lateralization as Indicated by Neuroimaging Correlates: Frontal-Parietal Laterality Index (LI) Scores - Baseline	0.14; 0.15; -0.19; 0.10	—
SECONDARY Change in Language Lateralization as Indicated by Neuroimaging Correlates: Frontal-Parietal Laterality Index (LI) Scores - Immediate Follow Up	0.10; 0.06; -0.03; -0.03	—
SECONDARY Change in Language Lateralization as Indicated by Neuroimaging Correlates: Frontal-Parietal Laterality Index (LI) Scores - Long-term Follow Up	0.21; -0.11; -0.02; 0.23	—
SECONDARY Change in Language Lateralization as Indicated by Neuroimaging Correlates: Cerebellum Laterality Index (LI) Scores - Baseline	-0.24; -0.05; -0.09; -0.23	—
SECONDARY Change in Language Lateralization as Indicated by Neuroimaging Correlates: Cerebellum Laterality Index (LI) Scores - Immediate Follow Up	0.06; -0.22; 0.01; -0.33	—
SECONDARY Change in Language Lateralization as Indicated by Neuroimaging Correlates: Cerebellum Laterality Index (LI) Scores - Long-term Follow Up	-0.08; 0.02; 0.08; -0.28	—

Summary

In this study the investigators will examine the efficacy of navigated excitatory repetitive transcranial magnetic stimulation (nerTMS) for the treatment of post stroke aphasia. The investigators expect that this new types of rehabilitation (nerTMS) will help patients with aphasia return to their lives as they were prior to the stroke.

Eligibility Criteria

Inclusion Criteria

Age ≥ 18 years
LMCA stroke as indicated by the presence of aphasia and MRI lesion in the LMCA distribution
Moderate aphasia (Token Test score between 40th and 90th percentile)
Fluency in English
Provision of written informed consent by the patient and/or the next of kin

Exclusion Criteria

Age less than 18 years
Underlying degenerative or metabolic disorder or supervening medical illness
Severe depression or other psychiatric disorder
Positive pregnancy test in women of childbearing age
Any contraindication to MRI/fMRI at 3T (i.e., intracranial metal implants, claustrophobia)
Any contraindication to nerTMS (e.g., seizures or epilepsy)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01512264). 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.