StrokeMITTXSNCT06213376
MIT Intensive Treatment Study
A study testing Melodic Intonation Therapy and Video Feedback Performance Review in people with Stroke and Aphasia, run by Nevada State University at 1 site in United States.
Trial summary
This study is examining the use of intensive melodic intonation therapy and video feedback as a means of aiding individuals with nonfluent aphasia and co-occurring motor speech impairments. Individuals with nonfluent aphasia have difficulty with language, particularly with word retrieval. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Aphasia, Motor Speech
- What is being tested?
- Melodic Intonation Therapy and Video Feedback Performance Review
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Dec 2023to 23 Feb 2024
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fluent English speakers
- Sustained a left-hemisphere stroke
- Presents with language and motor speech impairments
Who cannot join
- • History of learning disability prior to accident (per patient report)
- Uncorrected auditory or visual impairments
- Not meeting the criteria of stroke
- Failure to provide evidence of stroke diagnosis (medical record history)
- History of psychiatric disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intensive MIT Paired With Video Feedback for Motor Speech Disorders and Aphasia
This study is examining the use of intensive melodic intonation therapy and video feedback as a means of aiding individuals with nonfluent aphasia and co-occurring motor speech impairments. Individuals with nonfluent aphasia have difficulty with language, particularly with word retrieval.
- Conditions
- Stroke, Aphasia, Motor Speech
- Being tested
- Melodic Intonation Therapy, Video Feedback Performance Review
- Medical subject headings
- Stroke, Aphasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melodic Intonation TherapyBehavioural
Melodic Intonation Therapy uses intonation and melody to aid individuals with aphasia with producing words.
Video Feedback Performance ReviewBehavioural
Participant will view recording to judge correct and incorrect productions of trained words and to identify motor techniques increasing intelligibility
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 20 sessions/4 weeks:
Video Feedback:
S1) Participant (P1) views recording of previous session with the clinician \& judges whether the production is intelligible.
S2) S1 \& the clinician identifies changes in motor movements that are influencing performance.
S3+S4) S1+S2 \& given support from the clinician, P1 identifies techniques improving intelligibility \& modifies behavior accordingly.
MIT (Albert et al., 1973; Helm-Estabrooks et al., 2014):
Humming - Clinician introduces the target phrase by showing a visual cue, humming the phrase, then intoning the phrase while P1 taps left-hand.
Simultaneous production with melody - The Clinician and P1 melodically produce the target phrase \& tap together.
Simultaneous melodic production accompanied by gradual reduction of clinician support.
Immediate repetition response to probe question - Following P1's successful repetition, the clinician melodically produces a question and P1 melodically produces the target. Receives: Behavioral: Melodic Intonation Therapy; Behavioral: Video Feedback Performance Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intelligibility
Intelligibility as measured by percentage of consonants correct and by targets produced on trained and untrained stimuli. 20 trained and 20 untrained speech phrases that are relevant to the client (measured during reading and repetition tasks)
Measured: From enrollment to 4 weeks post treatment
Secondary outcomes (4)
Apraxia Battery for Adults
A test to measure the presence and severity of apraxia in adults
Measured: Baseline and one week following the end of treatment
Assessment of Intelligibility of Dysarthria Speech
A tool for quantifying single-word intelligibility, sentence intelligibility, and speaking rate of adult speakers with dysarthria
Measured: Baseline and one week following the end of treatment
Longer Connected Speech Assessment
Change in Performance on Rainbow Passage- A public domain paragraph frequently used by speech-language pathologists to gather a speech sample of all phonemes for American English
Measured: Baseline and one and four weeks following the end of treatment
Quality of Life with Dysarthria (QOLdys)
A reliable and valid tool to assess quality of life for patients with dysarthria.
Measured: Baseline and four weeks following treatments.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start28 Dec 2023
- Primary completion23 Feb 2024
- Study completion23 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-subject experimental design
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nevada State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andre Lindsey, Nevada State University
- Investigators
- Andre Lindsey, PhD, Principal investigator, Nevada State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06213376
- Sponsor's protocol ID
- 2312-0370
- Acronym
- MITTXS
- Status last verified
- Aug 2024
- First submitted
- 9 Jan 2024
- Last updated
- 30 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Albert ML, Sparks RW, Helm NA. Melodic intonation therapy for aphasia. Arch Neurol. 1973 Aug;29(2):130-1. doi: 10.1001/archneur.1973.00490260074018. No abstract available.
PubMed 4717723Helm-Estabrooks, N., Albert, M. L., & Nicholas, M. (2014). Manual of aphasia and aphasia therapy (3rd ed.). Austin, TX: Pro-Ed
Zumbansen A, Peretz I, Hebert S. Melodic intonation therapy: back to basics for future research. Front Neurol. 2014 Jan 28;5:7. doi: 10.3389/fneur.2014.00007. eCollection 2014.
PubMed 24478754
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive MIT Paired With Video Feedback for Motor Speech Disorders and Aphasia
- ClinicalTrials.gov ID
- NCT06213376
- Acronym / sponsor ID
- MITTXS / 2312-0370
- Conditions
- Stroke, Aphasia, Motor Speech
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Nevada State UniversityUniversity, hospital or other
- Study start
- 28 Dec 2023 (actual)
- Primary completion
- 23 Feb 2024 (actual)
- Study completion
- 23 Feb 2024 (actual)
- First posted
- 19 Jan 2024 (actual)
- 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.
This study is examining the use of intensive melodic intonation therapy and video feedback as a means of aiding individuals with nonfluent aphasia and co-occurring motor speech impairments. Individuals with nonfluent aphasia have difficulty with language, particularly with word retrieval.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-subject experimental design
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Melodic Intonation Therapy, Behavioral: Video Feedback Performance Review20 sessions/4 weeks: Video Feedback: S1) Participant (P1) views recording of previous session with the clinician \& judges whether the production is intelligible. S2) S1 \& the clinician identifies changes in motor movements that are influencing performance. S3+S4) S1+S2 \& given support from the clinician, P1 identifies techniques improving intelligibility \& modifies behavior accordingly. MIT (Albert et al., 1973; Helm-Estabrooks et al., 2014): Humming - Clinician introduces the target phrase by showing a visual cue, humming the phrase, then intoning the phrase while P1 taps left-hand. Simultaneous production with melody - The Clinician and P1 melodically produce the target phrase \& tap together. Simultaneous melodic production accompanied by gradual reduction of clinician support. Immediate repetition response to probe question - Following P1's successful repetition, the clinician melodically produces a question and P1 melodically produces the target. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Fluent English speakers
- Sustained a left-hemisphere stroke
- Presents with language and motor speech impairments
Key exclusion criteria (5 listed)
- • History of learning disability prior to accident (per patient report)
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 TherapyMelodic Intonation Therapy uses intonation and melody to aid individuals with aphasia with producing words. | Behavioural | Intervention |
| Video Feedback Performance ReviewParticipant will view recording to judge correct and incorrect productions of trained words and to identify motor techniques increasing intelligibility | Behavioural | Intervention |
Primary outcome
Intelligibility
Time frame: From enrollment to 4 weeks post treatment
Intelligibility as measured by percentage of consonants correct and by targets produced on trained and untrained stimuli. 20 trained and 20 untrained speech phrases that are relevant to the client (measured during reading and repetition tasks)
4 secondary outcomes
Apraxia Battery for Adults
Time frame: Baseline and one week following the end of treatment
Assessment of Intelligibility of Dysarthria Speech
Time frame: Baseline and one week following the end of treatment
Longer Connected Speech Assessment
Time frame: Baseline and one and four weeks following the end of treatment
Quality of Life with Dysarthria (QOLdys)
Time frame: Baseline and four weeks following treatments.
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 30 Aug 2024.
- Background: PubMed 4717723Albert ML, Sparks RW, Helm NA. Melodic intonation therapy for aphasia. Arch Neurol. 1973 Aug;29(2):130-1. doi: 10.1001/archneur.1973.00490260074018. No abstract available.
- BackgroundHelm-Estabrooks, N., Albert, M. L., & Nicholas, M. (2014). Manual of aphasia and aphasia therapy (3rd ed.). Austin, TX: Pro-Ed
- Background: PubMed 24478754Zumbansen A, Peretz I, Hebert S. Melodic intonation therapy: back to basics for future research. Front Neurol. 2014 Jan 28;5:7. doi: 10.3389/fneur.2014.00007. eCollection 2014.
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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.
Andre Lindsey, PhD principal investigator
Nevada State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Melodic Intonation Therapy and Video Feedback Performance Review in people with Stroke and Aphasia, run by Nevada State University 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 3 inclusion and 5 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 30 Aug 2024. 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.
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?
Intelligibility (time frame: From enrollment to 4 weeks post treatment). 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 NCT06213376, which also lists 3 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 30 Aug 2024.