AphasiaPhase 3NCT00903266
Melodic-Intonation-Therapy and Speech-Repetition-Therapy for Patients With Non-fluent Aphasia
A Phase 3 study testing Melodic Intonation Therapy and Speech-Repetition-Therapy in people with Aphasia and Stroke, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Aphasia, Stroke, Cerebrovascular Accident
- What is being tested?
- Melodic Intonation Therapy and Speech-Repetition-Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Jun 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center / Harvard Medical School
Boston, Massachusetts, 02215
About this study
Official title: Behavioral and Neural Correlates of Melodic-Intonation-Therapy (MIT) and Speech-Repetition-Therapy (SRT) 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.
Read the 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.
- Conditions
- Aphasia, Stroke, Cerebrovascular Accident, Apoplexy, Cerebral Infarction
- Being tested
- Melodic Intonation Therapy, Speech-Repetition-Therapy
- Keywords
- Aphasia, Speech Impairment, Stroke, Cerebrovascular Accident, Cerebral Infarction, Brain Ischemia, Brain Infarction, Cerebrovascular Disorder
- Medical subject headings
- Aphasia, Stroke, Cerebral Infarction, Speech Disorders, Brain Ischemia, Brain Infarction, Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melodic Intonation TherapyBehavioural
MIT emphasizes the prosody of speech through the use of slow, pitched vocalization (singing).
Speech-Repetition-TherapyBehavioural
Speech-Reception-Therapy is an equally intensive, alternative verbal treatment method developed for this study.
| Study group | Role | What they receive |
|---|---|---|
| MIT | Experimental | Melodic Intonation Therapy Receives: Behavioral: Melodic Intonation Therapy |
| SRT | Active comparator | Speech-Repetition-Therapy Receives: Behavioral: Speech-Repetition-Therapy |
| NTC | No intervention | No-Therapy Control; Patients in this arm will be re-randomized to the two active arms at the end of the NTC period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correct Information Units (CIU)/min and CIUs/phrase elicited during spontaneous speech
Measured: 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
Measured: baseline (x2), midpoint of therapy, end of therapy, 4 weeks after end of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2009 (estimated)
- Study startFeb 2008
- Primary completionMay 2020
- Study completionJun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AphasiaStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Principal investigator, Gottfried Schlaug, Beth Israel Deaconess Medical Center
- Investigators
- Gottfried Schlaug, MD, PhD, Principal investigator, Beth Israel Deaconess Medical Center / Harvard Medical SchoolAndrea Norton, BM, Study director, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00903266
- Sponsor's protocol ID
- DC008796
- Other IDs
- 3R01DC008796-02S1, R01DC008796
- Status last verified
- Sep 2020
- First submitted
- 15 May 2009
- Last updated
- 21 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16956772Norton 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.
PubMed 19673819Schlaug 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.
PubMed 21197418Schlaug 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.
PubMed 19673813
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral and Neural Correlates of Melodic-Intonation-Therapy (MIT) and Speech-Repetition-Therapy (SRT) for Patients With Non-fluent Aphasia
- ClinicalTrials.gov ID
- NCT00903266
- Acronym / sponsor ID
- DC008796
- Conditions
- Aphasia, Stroke, Cerebrovascular Accident, Apoplexy, Cerebral Infarction
- Keywords
- Aphasia, Speech Impairment, Stroke, Cerebrovascular Accident, Cerebral Infarction, Brain Ischemia, Brain Infarction, Cerebrovascular Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- Feb 2008
- Primary completion
- May 2020 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 18 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MIT | Experimental | Behavioral: Melodic Intonation TherapyMelodic Intonation Therapy |
| SRT | Active comparator | Behavioral: Speech-Repetition-TherapySpeech-Repetition-Therapy |
| NTC | No intervention | –No-Therapy Control; Patients in this arm will be re-randomized to the two active arms at the end of the NTC period. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Melodic Intonation TherapyMIT emphasizes the prosody of speech through the use of slow, pitched vocalization (singing). | Behavioural | MIT |
| Speech-Repetition-TherapySpeech-Reception-Therapy is an equally intensive, alternative verbal treatment method developed for this study. | Behavioural | SRT |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2020.
- Background: PubMed 16956772Ozdemir 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.
- Background: PubMed 19673819Norton 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 publication: PubMed 21197418Schlaug 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 publication: PubMed 19673813Schlaug 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.
- Under "projects" we provide details of our aphasia studies and other studies currently going on in our laboratory.Link provided by the sponsor.
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Not yet recruitingObservational study
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Stroke, Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gottfried Schlaug, MD, PhD principal investigator
Beth Israel Deaconess Medical Center / Harvard Medical School
Andrea Norton, BM study director
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Melodic Intonation Therapy and Speech-Repetition-Therapy in people with Aphasia and Stroke, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00903266, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2020.