Melodic-Intonation-Therapy and Speech-Repetition-Therapy for Patients With Non-fluent Aphasia
Primary Purpose
Aphasia, Stroke, Cerebrovascular Accident
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Melodic Intonation Therapy
Speech-Repetition-Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Aphasia focused on measuring Aphasia, Speech Impairment, Stroke, Cerebrovascular Accident, Cerebral Infarction, Brain Ischemia, Brain Infarction, Cerebrovascular Disorder
Eligibility Criteria
Inclusion Criteria:
- 21-80 years of age
- first-time ischemic left-hemispheric stroke or cerebrovascular accident
- at least 12 months out from first ischemic stroke
- right-handed (prior to stroke)
- diagnosis of non-fluent or dysfluent aphasia
Exclusion Criteria:
- older than 80 years of age
- more than 1 stroke
- presence of metal or metallic or electronic devices that cannot be exposed to the MRI environment
- a terminal medical condition; history of major neurological or psychiatric diseases (e.g. epilepsy; meningitis, encephalitis)
- use of psychoactive drugs/medications such as antidepressants, antipsychotic, stimulants
- active participation in other stroke recovery trials testing experimental interventions
Sites / Locations
- Beth Israel Deaconess Medical Center / Harvard Medical School
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
MIT
SRT
NTC
Arm Description
Melodic Intonation Therapy
Speech-Repetition-Therapy
No-Therapy Control; Patients in this arm will be re-randomized to the two active arms at the end of the NTC period.
Outcomes
Primary Outcome Measures
Correct Information Units (CIU)/min and CIUs/phrase elicited during spontaneous speech
Secondary Outcome Measures
1) Items named on a standard picture naming test; 2) timed automatic speech; 3) linguistically-based measures of phrase and sentence analysis; 4) functional and structural imaging measures
Full Information
NCT ID
NCT00903266
First Posted
May 15, 2009
Last Updated
September 17, 2020
Sponsor
Beth Israel Deaconess Medical Center
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
1. Study Identification
Unique Protocol Identification Number
NCT00903266
Brief Title
Melodic-Intonation-Therapy and Speech-Repetition-Therapy for Patients With Non-fluent Aphasia
Official Title
Behavioral and Neural Correlates of Melodic-Intonation-Therapy (MIT) and Speech-Repetition-Therapy (SRT) for Patients With Non-fluent Aphasia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
May 2020 (Actual)
Study Completion Date
June 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
We are doing this clinical trial in order to evaluate two different treatments for non-fluent aphasia: Melodic Intonation Therapy (MIT) and Speech Repetition Therapy (SRT). MIT uses a simple form of singing, while SRT uses intensive repetition of a set of words and phrases. We want to see which intensive form of treatment is more effective in leading to an improvement in speech output compared to a no-therapy control period, and whether either treatment can cause changes in brain activity during speaking and changes in brain structure. We will use a technique known as functional Magnetic Resonance Imaging (fMRI) to measure blood flow changes in the brain and structural MRI that assess brain anatomy and connections between brain regions. We will use fMRI to assess brain activity while a patient speaks, sings, and hums. We will assess changes in brain activity and in brain structure by comparing scans done prior to treatment to scans obtained after treatment and we will also examine changes between treatment groups. We will correlate changes in brain activity and brain structure with changes in language test scores.
Detailed Description
One of the few accepted treatments for severe non-fluent aphasia is Melodic Intonation Therapy (MIT). Inspired by the common clinical observation that patients can actually sing the lyrics of a song better than they can speak the same words, MIT emphasizes the prosody of speech through the use of slow, pitched vocalization (singing), and has been shown to lead to significant improvements in propositional speech beyond the actual treatment period. It has been hypothesized that this effect is due to the gradual recruitment of right-hemispheric language regions for normal speech production, and this is further supported by our functional magnetic resonance imaging (fMRI) pilot data. Although the MIT-induced treatment effect has been shown in several small case series, it is not clear whether the effect is due to the intensity of the treatment or to the unique, components of MIT that are not found in other, non-intonation-based interventions. Thus, our overall aim is to test our hypothesis that MIT's rehabilitative effect is achieved by using its melodic and rhythmic elements to engage and/or unmask the predominantly right-hemispheric brain regions capable of supporting expressive language function. In order to test this hypothesis, we have developed an experimental design that includes the randomization of chronic stroke patients with persistent, moderate to severe non-fluent aphasia into three parallel groups receiving 1) 75 sessions of Melodic Intonation Therapy (approximately 15 weeks), 2) 75 sessions of an equally intensive, alternative verbal treatment method developed for this study (Speech Repetition Therapy), or 3) an equal period of No Therapy. All patients will undergo two pre-therapy and two post-therapy behavioral assessments in addition to the pre- and post-therapy fMRI studies and structural MRI studies examining the neural correlates of overtly spoken and sung words and phrases.This design allows us to 1) examine the efficacy of MIT over No Therapy, 2) examine the effects of elements specific to MIT (e.g., melodic intonation and rhythmic tapping) by comparing it to a control intervention (SRT) that is similar in structure and intensity of treatment, 3) compare post-therapy effects with pre-therapy baseline variations, and 4) examine post-treatment maintenance effects. Our primary speech outcome measure will be the number of Correct Information Units (CIU)/min produced during spontaneous speech. Secondary outcome measures include correctly named items on standard picture naming tests, timed automatic speech, and linguistically-based measures of phrase and sentence analysis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia, Stroke, Cerebrovascular Accident, Apoplexy, Cerebral Infarction
Keywords
Aphasia, Speech Impairment, Stroke, Cerebrovascular Accident, Cerebral Infarction, Brain Ischemia, Brain Infarction, Cerebrovascular Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MIT
Arm Type
Experimental
Arm Description
Melodic Intonation Therapy
Arm Title
SRT
Arm Type
Active Comparator
Arm Description
Speech-Repetition-Therapy
Arm Title
NTC
Arm Type
No Intervention
Arm Description
No-Therapy Control; Patients in this arm will be re-randomized to the two active arms at the end of the NTC period.
Intervention Type
Behavioral
Intervention Name(s)
Melodic Intonation Therapy
Intervention Description
MIT emphasizes the prosody of speech through the use of slow, pitched vocalization (singing).
Intervention Type
Behavioral
Intervention Name(s)
Speech-Repetition-Therapy
Intervention Description
Speech-Reception-Therapy is an equally intensive, alternative verbal treatment method developed for this study.
Primary Outcome Measure Information:
Title
Correct Information Units (CIU)/min and CIUs/phrase elicited during spontaneous speech
Time Frame
Baseline (x2), midpoint of therapy, end of therapy, 4 weeks after end of therapy
Secondary Outcome Measure Information:
Title
1) Items named on a standard picture naming test; 2) timed automatic speech; 3) linguistically-based measures of phrase and sentence analysis; 4) functional and structural imaging measures
Time Frame
baseline (x2), midpoint of therapy, end of therapy, 4 weeks after end of therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
21-80 years of age
first-time ischemic left-hemispheric stroke or cerebrovascular accident
at least 12 months out from first ischemic stroke
right-handed (prior to stroke)
diagnosis of non-fluent or dysfluent aphasia
Exclusion Criteria:
older than 80 years of age
more than 1 stroke
presence of metal or metallic or electronic devices that cannot be exposed to the MRI environment
a terminal medical condition; history of major neurological or psychiatric diseases (e.g. epilepsy; meningitis, encephalitis)
use of psychoactive drugs/medications such as antidepressants, antipsychotic, stimulants
active participation in other stroke recovery trials testing experimental interventions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gottfried Schlaug, MD, PhD
Organizational Affiliation
Beth Israel Deaconess Medical Center / Harvard Medical School
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrea Norton, BM
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center / Harvard Medical School
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
16956772
Citation
Ozdemir E, Norton A, Schlaug G. Shared and distinct neural correlates of singing and speaking. Neuroimage. 2006 Nov 1;33(2):628-35. doi: 10.1016/j.neuroimage.2006.07.013. Epub 2006 Sep 7.
Results Reference
background
PubMed Identifier
19673819
Citation
Norton A, Zipse L, Marchina S, Schlaug G. Melodic intonation therapy: shared insights on how it is done and why it might help. Ann N Y Acad Sci. 2009 Jul;1169:431-6. doi: 10.1111/j.1749-6632.2009.04859.x.
Results Reference
background
PubMed Identifier
21197418
Citation
Schlaug G, Marchina S, Norton A. From Singing to Speaking: Why Singing May Lead to Recovery of Expressive Language Function in Patients with Broca's Aphasia. Music Percept. 2008 Apr 1;25(4):315-323. doi: 10.1525/MP.2008.25.4.315.
Results Reference
result
PubMed Identifier
19673813
Citation
Schlaug G, Marchina S, Norton A. Evidence for plasticity in white-matter tracts of patients with chronic Broca's aphasia undergoing intense intonation-based speech therapy. Ann N Y Acad Sci. 2009 Jul;1169:385-94. doi: 10.1111/j.1749-6632.2009.04587.x.
Results Reference
result
Links:
URL
http://www.musicianbrain.com
Description
Under "projects" we provide details of our aphasia studies and other studies currently going on in our laboratory.
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Melodic-Intonation-Therapy and Speech-Repetition-Therapy for Patients With Non-fluent Aphasia
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