DementiaNCT04221386
Melodic Intonation Therapy for Tone Language Speakers
A study testing Melodic Intonation Therapy (MIT) in people with Dementia and Speech Therapy, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
One of the traditional therapies for restoring the ability of speech in aphasic patients is Melodic Intonation Therapy (MIT), in which everyday phrases are taught in a singing-like manner. Read more about this study
- Who is it for?
- Ages 50 to 100 years
- Conditions the study is for
- Dementia, Speech Therapy
- What is being tested?
- Melodic Intonation Therapy (MIT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Aug 2020to 28 Feb 2021
- 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 50 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Early to moderate stage dementia patient
- Normal hearing (hearing aid accepted)
- Non-fluent speech (max. score of fluency in Cantonese Aphasia Battery spontaneous speech subtest = 6/10)
Who cannot join
- Non-native Cantonese speaker
- Illiterate
- Aphasic patients
- Subjects who receive other speech therapy during study
Trial locations and contacts
1 site in 1 country.
About this study
One of the traditional therapies for restoring the ability of speech in aphasic patients is Melodic Intonation Therapy (MIT), in which everyday phrases are taught in a singing-like manner. The suggested mechanism for speech recovery is that because of the sharing of brain resources for language and music, the regions normally reserved for singing can be trained to help compensate the speech functions originally subserved by the damaged regions. However, this therapy has primarily been applied to speakers of non-tone languages, in which prosodic features carry a more important role than pitch features in conveying meanings. It remains unknown whether MIT will be equally applicable for speakers of tone languages, in which pitch features likely play a more important role. Another uncertainty concerns whether the efficacy of MIT can be extended to patients with expressive speech impairment due to dementia. This pilot study aims to find out the efficacy of MIT for speech-impaired dementia patients in different verbal tasks. The results of this study will provide preliminary empirical evidence to establish the utility of MIT for Cantonese speakers in Hong Kong.
- Conditions
- Dementia, Speech Therapy
- Being tested
- Melodic Intonation Therapy (MIT)
- Keywords
- Melodic Intonation Therapy, Music, Tone language
- Medical subject headings
- Dementia, Communication Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melodic Intonation Therapy (MIT)Behavioural
Subjects will receive at least 6 MIT sessions in group of 3-5 subjects. In the sessions, experimenter will sing songs with the subjects. Songs used in the intervention are familiar to elderly and are rewritten and embedded with everyday phrases and vocabularies. The whole intervention will span 3-4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| MIT group | Experimental | Subjects will receive the developed Melodic Intonation Therapy. Receives: Behavioral: Melodic Intonation Therapy (MIT) |
| Control group | No intervention | Subjects will not receive any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Aphasia Quotient (AQ) in Cantonese Aphasia Battery
Two subtests of the Cantonese Aphasia Battery (auditory comprehension \& spontaneous speech) will be executed. Higher AQ means better performance in the respective areas. The minimum of AQ in each subtest is 0, and the maximum is 20.
Measured: within a week after procedure
Secondary outcomes (2)
Change in latency and accuracy in picture naming task
In the computerized picture naming task, subjects are asked to name the objects they see in 52 pictures, within 5000 ms per picture. Visual stimuli of the task are black and white line-drawings. Responses are all recorded for analysis.
Measured: within a week after procedure
Change in performance of semantic fluency task
In the computerized semantic fluency task, subjects are given 5 categories (e.g. animals) and asked to name as many members of the categories (e.g. cat, dog) as possible. For each category, they have one minute to respond. All the responses are recorded for analysis.
Measured: within a week after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2020
- Study start1 Aug 2020 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion28 Feb 2021 (estimated)
Why it stopped: Coronavirus
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 DementiaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William Shi Yuan Wang, Ph.D., Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04221386
- Sponsor's protocol ID
- IZZKJ
- Status last verified
- Dec 2019
- First submitted
- 3 Jan 2020
- Last updated
- 10 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All the data collected in screening, pre- and post-assessment will not be shared with other researchers.
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 4717723Sparks R, Helm N, Albert M. Aphasia rehabilitation resulting from melodic intonation therapy. Cortex. 1974 Dec;10(4):303-16. doi: 10.1016/s0010-9452(74)80024-9. No abstract available.
PubMed 4452250Sarkamo T, Sihvonen AJ. Golden oldies and silver brains: Deficits, preservation, learning, and rehabilitation effects of music in ageing-related neurological disorders. Cortex. 2018 Dec;109:104-123. doi: 10.1016/j.cortex.2018.08.034. Epub 2018 Sep 19.
PubMed 30312779
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Melodic Intonation Therapy for Tone Language Speakers
- ClinicalTrials.gov ID
- NCT04221386
- Acronym / sponsor ID
- IZZKJ
- Conditions
- Dementia, Speech Therapy
- Keywords
- Melodic Intonation Therapy, Music, Tone language
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Coronavirus
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Aug 2020 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 28 Feb 2021 (estimated)
- First posted
- 9 Jan 2020 (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.
One of the traditional therapies for restoring the ability of speech in aphasic patients is Melodic Intonation Therapy (MIT), in which everyday phrases are taught in a singing-like manner. The suggested mechanism for speech recovery is that because of the sharing of brain resources for language and music, the regions normally reserved for singing can be trained to help compensate the speech functions originally subserved by the damaged regions. However, this therapy has primarily been applied to speakers of non-tone languages, in which prosodic features carry a more important role than pitch features in conveying meanings. It remains unknown whether MIT will be equally applicable for speakers of tone languages, in which pitch features likely play a more important role. Another uncertainty concerns whether the efficacy of MIT can be extended to patients with expressive speech impairment due to dementia. This pilot study aims to find out the efficacy of MIT for speech-impaired dementia patients in different verbal tasks. The results of this study will provide preliminary empirical evidence to establish the utility of MIT for Cantonese speakers in Hong Kong.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MIT group | Experimental | Behavioral: Melodic Intonation Therapy (MIT)Subjects will receive the developed Melodic Intonation Therapy. |
| Control group | No intervention | –Subjects will not receive any intervention. |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Early to moderate stage dementia patient
- Normal hearing (hearing aid accepted)
- Non-fluent speech (max. score of fluency in Cantonese Aphasia Battery spontaneous speech subtest = 6/10)
Key exclusion criteria (4 listed)
- Non-native Cantonese speaker
- Illiterate
- Aphasic patients
- Subjects who receive other speech therapy during study
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 Therapy (MIT)Subjects will receive at least 6 MIT sessions in group of 3-5 subjects. In the sessions, experimenter will sing songs with the subjects. Songs used in the intervention are familiar to elderly and are rewritten and embedded with everyday phrases and vocabularies. The whole intervention will span 3-4 weeks. | Behavioural | MIT group |
Primary outcome
Change in Aphasia Quotient (AQ) in Cantonese Aphasia Battery
Time frame: within a week after procedure
Two subtests of the Cantonese Aphasia Battery (auditory comprehension \& spontaneous speech) will be executed. Higher AQ means better performance in the respective areas. The minimum of AQ in each subtest is 0, and the maximum is 20.
2 secondary outcomes
Change in latency and accuracy in picture naming task
Time frame: within a week after procedure
Change in performance of semantic fluency task
Time frame: within a week after procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2020.
- 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.
- Background: PubMed 4452250Sparks R, Helm N, Albert M. Aphasia rehabilitation resulting from melodic intonation therapy. Cortex. 1974 Dec;10(4):303-16. doi: 10.1016/s0010-9452(74)80024-9. No abstract available.
- Results publication: PubMed 30312779Sarkamo T, Sihvonen AJ. Golden oldies and silver brains: Deficits, preservation, learning, and rehabilitation effects of music in ageing-related neurological disorders. Cortex. 2018 Dec;109:104-123. doi: 10.1016/j.cortex.2018.08.034. Epub 2018 Sep 19.
- Individual participant dataSharing planned: No. All the data collected in screening, pre- and post-assessment will not be shared with other researchers.
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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.
William Shi Yuan Wang, Ph.D. principal investigator
The Hong Kong Polytechnic 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 (MIT) in people with Dementia and Speech Therapy, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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 4 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: paused, as of the sponsor's last update on 10 Apr 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 Hong Kong. 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?
Results are not available in the source record.
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?
Change in Aphasia Quotient (AQ) in Cantonese Aphasia Battery (time frame: within a week after procedure). 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 NCT04221386, 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 10 Apr 2020.