Melodic-Intonation-Therapy and Speech-Repetition-Therapy for Patients With Non-fluent Aphasia
Behavioral and Neural Correlates of Melodic-Intonation-Therapy (MIT) and Speech-Repetition-Therapy (SRT) for Patients With Non-fluent Aphasia
3 other identifiers
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Feb 2008
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 15, 2009
CompletedFirst Posted
Study publicly available on registry
May 18, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedSeptember 21, 2020
September 1, 2020
12.3 years
May 15, 2009
September 17, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Correct Information Units (CIU)/min and CIUs/phrase elicited during spontaneous speech
Baseline (x2), midpoint of therapy, end of therapy, 4 weeks after end of therapy
Secondary Outcomes (1)
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
baseline (x2), midpoint of therapy, end of therapy, 4 weeks after end of therapy
Study Arms (3)
MIT
EXPERIMENTALMelodic Intonation Therapy
SRT
ACTIVE COMPARATORSpeech-Repetition-Therapy
NTC
NO INTERVENTIONNo-Therapy Control; Patients in this arm will be re-randomized to the two active arms at the end of the NTC period.
Interventions
MIT emphasizes the prosody of speech through the use of slow, pitched vocalization (singing).
Speech-Reception-Therapy is an equally intensive, alternative verbal treatment method developed for this study.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beth Israel Deaconess Medical Center / Harvard Medical School
Boston, Massachusetts, 02215, United States
Related Publications (4)
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.
PMID: 16956772BACKGROUNDNorton 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.
PMID: 19673819BACKGROUNDSchlaug 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.
PMID: 21197418RESULTSchlaug 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.
PMID: 19673813RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gottfried Schlaug, MD, PhD
Beth Israel Deaconess Medical Center / Harvard Medical School
- STUDY DIRECTOR
Andrea Norton, BM
Beth Israel Deaconess Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Neurology; Staff Neurologist
Study Record Dates
First Submitted
May 15, 2009
First Posted
May 18, 2009
Study Start
February 1, 2008
Primary Completion
May 1, 2020
Study Completion
June 1, 2020
Last Updated
September 21, 2020
Record last verified: 2020-09