Melodic-Intonation-Therapy and Speech-Repetition-Therapy for Patients With Non-fluent Aphasia
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.
Behavioral: Melodic Intonation Therapy
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Behavioral and Neural Correlates of Melodic-Intonation-Therapy (MIT) and Speech-Repetition-Therapy (SRT) for Patients With Non-fluent Aphasia|
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
|Study Start Date:||February 2008|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Melodic Intonation Therapy
Behavioral: Melodic Intonation Therapy
MIT emphasizes the prosody of speech through the use of slow, pitched vocalization (singing).
Active Comparator: SRT
Speech-Reception-Therapy is an equally intensive, alternative verbal treatment method developed for this study.
No Intervention: NTC
No-Therapy Control; Patients in this arm will be re-randomized to the two active arms at the end of the NTC period.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00903266
|Contact: Gottfried Schlaug, MD, PhDfirstname.lastname@example.org|
|Contact: Andrea Norton, BMemail@example.com|
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center / Harvard Medical School||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Gottfried Schlaug, MD, PhD 617-632-8926 firstname.lastname@example.org|
|Contact: Andrea Norton, BM 617-632-8926 email@example.com|
|Principal Investigator: Gottfried Schlaug, MD, PhD|
|Principal Investigator:||Gottfried Schlaug, MD, PhD||Beth Israel Deaconess Medical Center / Harvard Medical School|
|Study Director:||Andrea Norton, BM||Beth Israel Deaconess Medical Center|