Clinical trial NCT01512264: Post-Stroke Aphasia and Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment Study
Official title: Post-Stroke Aphasia and rTMS Treatment Study (PART)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aphasia
Stroke
Keywords: Aphasia
Stroke
functional Magnetic resonance imaging
fMRI
Language recovery after stroke
constraint induced aphasia therapy
CIAT
Repetitive transcranial magnetic stimulation
rTMS
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2012-01-19
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Aphasia after stroke is associated with high mortality, significant motor impairment, and severe limitations in social participation. During the past decade, therapies administered by stroke teams have made great strides to limit the motor impairments caused by stroke. Unfortunately, progress in aphasia rehabilitation has not experienced the same rapid advancement. This proposal is based on preliminary evidence from our recently completed pilot study which showed that navigated excitatory repetitive transcranial magnetic stimulation (nerTMS) targeted to residual activity in the affected hemisphere has a significant beneficial effect on post-stroke aphasia recovery.1 The main aim of this study is to conduct a double-blind, sham-controlled, dose-response nerTMS treatment trial in subjects with chronic aphasia. By conducting this comparative trial, we will provide clinical (qualitative and quantitative) and imaging evidence that nerTMS improves language function after stroke when compared to standard treatment (ST). The findings will have implications for patients with post-stroke aphasia in that once the study is completed and the results are available, rehabilitation specialists may be able to change their practice pattern by offering an additional tool to aid patients in recovering their language skills with improved participation in society and enhanced quality of life.

To fill the gap in our therapeutic arsenal for aphasia, we propose a study with the following specific aims: (1) to determine the comparative efficacy and optimal dosing of nerTMS on aphasia recovery using a randomized, double-blind, sham-controlled study design. Subjects (15/group) will be randomly assigned to 4 treatment groups: (a) 3 weeks of nerTMS, (b) 1 week of ST + 2 weeks of nerTMS, (c) 2 weeks of ST +1 week of nerTMS, or (d) 3 weeks of ST (control group). This design will allow systematic evaluation of the efficacy of nerTMS and will determine its most optimal dose for language recovery. Short- and long-term outcomes will be evaluated with aphasia testing (AT) and fMRI; (2) to use fMRI to assess changes in language lateralization in response to nerTMS. We will examine the relationship between the degree of pre-nerTMS language lateralization (fMRI) with the post-nerTMS language outcomes (AT) and determine whether fMRI language lateralization can predict AT performance following nerTMS targeted to the left middle cerebral artery (LMCA) stroke areas.

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)

Primary outcomes:
measure: Aphasia Testing as Evaluated by the Boston Naming Test (BNT) - Baseline
timeFrame: Baseline: 1 week before the first nerTMS treatment
measure: Aphasia Testing as Evaluated by the Boston Naming Test (BNT) - Immediate Follow-Up
timeFrame: within 1 week post treatment
measure: Aphasia Testing as Evaluated by the Boston Naming Test (BNT) - Long Term Follow-up
timeFrame: 3 months post treatment
measure: Aphasia Testing as Evaluated by the Semantic Fluency Test (SFT) - Baseline
timeFrame: 1 week before the first nerTMS treatment
measure: Aphasia Testing as Evaluated by the Semantic Fluency Test (SFT) - Immediate Follow-up
timeFrame: within 1 week post treatment
measure: Aphasia Testing as Evaluated by the Semantic Fluency Test (SFT) - Long Term Follow-up
timeFrame: 3 months post treatment
measure: Aphasia Testing as Evaluated by the Controlled Word Association Test (COWAT) - Baseline
timeFrame: 1 week before the first nerTMS treatment
measure: Aphasia Testing as Evaluated by the Controlled Word Association Test (COWAT) - Immediate Follow-up
timeFrame: within 1 week post treatment
measure: Aphasia Testing as Evaluated by the Controlled Word Association Test (COWAT) - Long Term Follow-up
timeFrame: 3 months post treatment
measure: Western Aphasia Battery (WAB) - Baseline
timeFrame: Baseline: 1 week before the first nerTMS treatment
measure: Western Aphasia Battery (WAB) - Immediate Follow-Up
timeFrame: within 1 week post treatment
measure: Western Aphasia Battery (WAB) - Long-Term Follow-Up
timeFrame: 3 months post treatment
Secondary outcomes:
measure: Change in Language Laterilazation as Indicated by Neuroimaging Correlates: Frontal Laterality Index (LI) Scores - Baseline
timeFrame: Baseline: 1 week before the first nerTMS treatment
measure: Change in Language Lateralization as Indicated by Neuroimaging Correlates: Frontal Laterality Index (LI) Scores - Immediate Follow-up
timeFrame: within 1 week post treatment
measure: Change in Language Lateralization as Indicated by Neuroimaging Correlates: Frontal Laterality Index (LI) Scores - Long-term Follow Up
timeFrame: 3 months post treatment
measure: Change in Language Lateralization as Indicated by Neuroimaging Correlates: Frontal-Parietal Laterality Index (LI) Scores - Baseline
timeFrame: Baseline: 1 week before the first nerTMS treatment
measure: Change in Language Lateralization as Indicated by Neuroimaging Correlates: Frontal-Parietal Laterality Index (LI) Scores - Immediate Follow Up
timeFrame: within 1 week post treatment
measure: Change in Language Lateralization as Indicated by Neuroimaging Correlates: Frontal-Parietal Laterality Index (LI) Scores - Long-term Follow Up
timeFrame: 3 months post treatment
measure: Change in Language Lateralization as Indicated by Neuroimaging Correlates: Cerebellum Laterality Index (LI) Scores - Baseline
timeFrame: Baseline: 1 week before the first nerTMS treatment
measure: Change in Language Lateralization as Indicated by Neuroimaging Correlates: Cerebellum Laterality Index (LI) Scores - Immediate Follow Up
timeFrame: within 1 week post treatment
measure: Change in Language Lateralization as Indicated by Neuroimaging Correlates: Cerebellum Laterality Index (LI) Scores - Long-term Follow Up
timeFrame: 3 months post treatment
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Jerzy P Szaflarski, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: