StrokeNCT03684603
Acoustic Cueing During Slow-wave Sleep as a Measure to Improve Motor Rehabilitation Outcome in Stroke Patients
A study testing melody during motor training and slow wave sleep and melody only during motor training in people with Stroke, run by Christian Baumann at 1 site in Switzerland.
Trial summary
This project aims at gaining insight into the role of sleep in motor learning and the first to apply sleep related learning methods in a rehabilitative setting. The primary objective is to investigate whether there is an effect of acoustic cueing during slow wave sleep on a specific motor task. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- melody during motor training and slow wave sleep and melody only during motor training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Nov 2017to 1 Apr 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and Female patients above 18 years of age
- signed informed consent after being informed
- subacute (i.e. symptom onset 3 - 90 days ago) lateralized ischemia or hemorrhage as confirmed by brain imaging (CT or MRI).
- Fugl-Meyer Upper Extremity Score between 15 and 59
Who cannot join
- other neurological or systemic disorder which is likely to cause dementia, cognitive dysfunction or central motor symptoms
- severe sensory aphasia
- preexisting arm paresis
- intake of sedatives, or neuroleptics
- Relevant hearing loss
- Vulnerable Person
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acoustic Cueing During Slow-wave Sleep as a Measure to Improve Motor Rehabilitation Outcome in Patients With Ischemic Stroke
This project aims at gaining insight into the role of sleep in motor learning and the first to apply sleep related learning methods in a rehabilitative setting. The primary objective is to investigate whether there is an effect of acoustic cueing during slow wave sleep on a specific motor task. The second objective is to investigate whether this effect can also be transferred to generalized motor rehabilitation outcome. Patients with an impairment of the arm function are randomized to either receiving the intervention ("cueing group") or to the control group. The patients are all listening to a melody during motor training but only the patients of the cueing group are also exposed to the melody during subsequent slow wave sleep. Performance gain is measured using an instrumented arm orthosis which is used for functional arm therapy over the sudy period of 5 consecutive days as well as during standard clinical assessments.
Read the detailed description
This is an open prospective pilot study. We plan to include 12 patients with stroke and to assign them into two groups (chosen by lot).
The patients will be tested to investigate the effect of cueing during slow-wave sleep on motor skill learning as well as on the general motor rehabilitation outcome (5 days). The study will be conducted in a controlled design while 6 patients will receive cueing whereas the other 6 control patients receive no cueing.
Study design: Effect of motor task-related acoustic cueing and motor recovery over 5 days of training On day 1 patient will have to perform different standardized short training tasks using the ArmeoSpring® system. Each of these tasks is designed to train speed and accuracy of movements whilst a leitmotif melody is played during the performance of the respective task. Every task will be performed twice at an easy and twice at a more difficult level. If one patient succeeds to reach a defined height of score at level 2 the patient will start with level 2 the next day and proceed to level 3 in order not to lose any measurable effect. The melody lasts for 5 to 10 seconds (similar to the design chosen by Antony et al 2012). The patients' movements will be measured during day and night with movement sensors, and during the training and clinical assessment sessions. Information about arm movement in relation to trunk movement is sent to a PC by wire transmission. Arm movements are translated into movements of an avatar (e.g. an arm-like structure) on the computer screen. Sensor measures will be transmitted via wire connection to a receiver, which is connected to a standard personal computer. Thus, this kinematic motion analysis system reconstructs all movements of the tested arm in real time. By moving this structure, the test subject can therefore fulfil a short task in a videogame-like environment (e.g. using technical items presented on the screen). Scores are given and visually presented to the patient.
During the following night patients will undergo electroencephalography (EEG) for the first time. Immediately before scheduled regular sleep hours, the EEG-Electrodes and the headphones (sleepphones® Classic) will be installed and EEG system (Embla® Titanium) will be started. The patients will sleep in their own normal hospital bed at the rehabilitation ward.
After onset of slow-wave-sleep as confirmed by online EEG, the melody will be played to the patients in the cueing group via headphones (sleepphones® Classic) in faint intensity (in-sleep-cueing without waking up the patient). Conversely patients of group 2 won't be exposed to the melody during sleep. Sound intensity will be similar to that of the background noise (approximately 35 dB sound pressure level). Once slow wave sleep finishes, the stimulation will also be stopped. Under ideal circumstances, the stimulation will be repeated in each slow-wave sleep phase. On day 2 - 5 the same motor tasks will be performed at the ArmeoSpring® device, with exposure to the respective melodies. The improvement in Scores will be will be measured.
During the following three nights the abovementioned procedures will be repeated.
On day 5 the motor tasks will again be performed at the ArmeoSpring® device without exposure to the respective melodies. The task scores will again be recorded and also the scores from the motor assessments will be taken in order to assess the general motor improvement over five days.
- Conditions
- Stroke
- Being tested
- melody during motor training and slow wave sleep, melody only during motor training
- Keywords
- Sleep, Acoustic Cueing
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
melody during motor training and slow wave sleepBehavioural
sequence of tones which are presented to the patient using earphones
melody only during motor trainingBehavioural
sequence of tones which are presented to the patient using earphones
| Study group | Role | What they receive |
|---|---|---|
| Acoustic cueing | Active comparator | The melody will be played during training and during slow wave sleep. Receives: Behavioral: melody during motor training and slow wave sleep |
| Control | Sham comparator | The melody will be played during training. Receives: Behavioral: melody only during motor training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in specific motor task
The primary outcome will be the improvement of the task-related scores in the two motor tasks at the ArmeoSpring® device for the first part. The task scores will be provided by the software (ArmeoControl®) itself. The task scores are displayed as an ordinal scale. Higher scores display a better outcome. For the first motor task the scores are displayed as volume in m^3, for the second one it will be measured in instability in cm and hand-path ratio s unknown variable but with a target value of 1.
Measured: 5 days
Secondary outcomes (2)
Correlation of motor learning curve and time of sleep cueing
The secondary outcome will be the correlation of the motor learning curve (e.g. standard clinical assessments) with the length of auditory stimulus application during the night. The standard clinical assessments like the Action Research Arm Test (ARAT) will be displayed as a score for each arm individually with a minimum of 0 and a maximum of 57 points. Higher scores indicate a better outcome. Therefore it will be analysed whether a higher length of auditory Stimulation correlates with a higher score in the ARAT.
Measured: 5 days
Improvement in generalized motor rehabilitation outcome
Also the correlation of (non-) response to in-sleep cueing with the clinical parameters (e.g. ARAT on an ordinal scale) taken will be analysed. The scores of e.g. the ARAT (see above) of patients in the control and the cueing group will be compared in order to allow for a statistical analysis concerning a correlation of (non-)response to auditory stimulation during the night.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study start1 Nov 2017
- Primary completion1 Jun 2020
- Study completion1 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christian Baumann
- Sponsor type
- University, hospital or other
- Collaborators
- Cereneo AG
- Responsible party
- Sponsor-investigator, Christian Baumann, University of Zurich
- Investigators
- Christian Baumann, MD, Study director, University Hospital Zurich, Clinic of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03684603
- Sponsor's protocol ID
- 2017-00199
- Other IDs
- 2017
- Status last verified
- Nov 2020
- First submitted
- 6 Sep 2018
- Last updated
- 20 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acoustic Cueing During Slow-wave Sleep as a Measure to Improve Motor Rehabilitation Outcome in Patients With Ischemic Stroke
- ClinicalTrials.gov ID
- NCT03684603
- Acronym / sponsor ID
- 2017-00199
- Conditions
- Stroke
- Keywords
- Sleep, Acoustic Cueing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Christian BaumannUniversity, hospital or other
- Collaborators
- Cereneo AG
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Apr 2021 (estimated)
- First posted
- 25 Sep 2018 (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 project aims at gaining insight into the role of sleep in motor learning and the first to apply sleep related learning methods in a rehabilitative setting. The primary objective is to investigate whether there is an effect of acoustic cueing during slow wave sleep on a specific motor task. The second objective is to investigate whether this effect can also be transferred to generalized motor rehabilitation outcome. Patients with an impairment of the arm function are randomized to either receiving the intervention ("cueing group") or to the control group. The patients are all listening to a melody during motor training but only the patients of the cueing group are also exposed to the melody during subsequent slow wave sleep. Performance gain is measured using an instrumented arm orthosis which is used for functional arm therapy over the sudy period of 5 consecutive days as well as during standard clinical assessments.
Detailed description
This is an open prospective pilot study. We plan to include 12 patients with stroke and to assign them into two groups (chosen by lot).
The patients will be tested to investigate the effect of cueing during slow-wave sleep on motor skill learning as well as on the general motor rehabilitation outcome (5 days). The study will be conducted in a controlled design while 6 patients will receive cueing whereas the other 6 control patients receive no cueing.
Study design: Effect of motor task-related acoustic cueing and motor recovery over 5 days of training On day 1 patient will have to perform different standardized short training tasks using the ArmeoSpring® system. Each of these tasks is designed to train speed and accuracy of movements whilst a leitmotif melody is played during the performance of the respective task. Every task will be performed twice at an easy and twice at a more difficult level. If one patient succeeds to reach a defined height of score at level 2 the patient will start with level 2 the next day and proceed to level 3 in order not to lose any measurable effect. The melody lasts for 5 to 10 seconds (similar to the design chosen by Antony et al 2012). The patients' movements will be measured during day and night with movement sensors, and during the training and clinical assessment sessions. Information about arm movement in relation to trunk movement is sent to a PC by wire transmission. Arm movements are translated into movements of an avatar (e.g. an arm-like structure) on the computer screen. Sensor measures will be transmitted via wire connection to a receiver, which is connected to a standard personal computer. Thus, this kinematic motion analysis system reconstructs all movements of the tested arm in real time. By moving this structure, the test subject can therefore fulfil a short task in a videogame-like environment (e.g. using technical items presented on the screen). Scores are given and visually presented to the patient.
During the following night patients will undergo electroencephalography (EEG) for the first time. Immediately before scheduled regular sleep hours, the EEG-Electrodes and the headphones (sleepphones® Classic) will be installed and EEG system (Embla® Titanium) will be started. The patients will sleep in their own normal hospital bed at the rehabilitation ward.
After onset of slow-wave-sleep as confirmed by online EEG, the melody will be played to the patients in the cueing group via headphones (sleepphones® Classic) in faint intensity (in-sleep-cueing without waking up the patient). Conversely patients of group 2 won't be exposed to the melody during sleep. Sound intensity will be similar to that of the background noise (approximately 35 dB sound pressure level). Once slow wave sleep finishes, the stimulation will also be stopped. Under ideal circumstances, the stimulation will be repeated in each slow-wave sleep phase. On day 2 - 5 the same motor tasks will be performed at the ArmeoSpring® device, with exposure to the respective melodies. The improvement in Scores will be will be measured.
During the following three nights the abovementioned procedures will be repeated.
On day 5 the motor tasks will again be performed at the ArmeoSpring® device without exposure to the respective melodies. The task scores will again be recorded and also the scores from the motor assessments will be taken in order to assess the general motor improvement over five days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acoustic cueing | Active comparator | Behavioral: melody during motor training and slow wave sleepThe melody will be played during training and during slow wave sleep. |
| Control | Sham comparator | Behavioral: melody only during motor trainingThe melody will be played during training. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and Female patients above 18 years of age
- signed informed consent after being informed
- subacute (i.e. symptom onset 3 - 90 days ago) lateralized ischemia or hemorrhage as confirmed by brain imaging (CT or MRI).
- Fugl-Meyer Upper Extremity Score between 15 and 59
Key exclusion criteria (6 listed)
- other neurological or systemic disorder which is likely to cause dementia, cognitive dysfunction or central motor symptoms
- severe sensory aphasia
- preexisting arm paresis
- intake of sedatives, or neuroleptics
- Relevant hearing loss
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 |
|---|---|---|
| melody during motor training and slow wave sleepsequence of tones which are presented to the patient using earphones | Behavioural | Acoustic cueing |
| melody only during motor trainingsequence of tones which are presented to the patient using earphones | Behavioural | Control |
Primary outcome
Improvement in specific motor task
Time frame: 5 days
The primary outcome will be the improvement of the task-related scores in the two motor tasks at the ArmeoSpring® device for the first part. The task scores will be provided by the software (ArmeoControl®) itself. The task scores are displayed as an ordinal scale. Higher scores display a better outcome. For the first motor task the scores are displayed as volume in m^3, for the second one it will be measured in instability in cm and hand-path ratio s unknown variable but with a target value of 1.
2 secondary outcomes
Correlation of motor learning curve and time of sleep cueing
Time frame: 5 days
Improvement in generalized motor rehabilitation outcome
Time frame: 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2020.
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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.
Christian Baumann, MD study director
University Hospital Zurich, Clinic of Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing melody during motor training and slow wave sleep and melody only during motor training in people with Stroke, run by Christian Baumann at 1 site in Switzerland.
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 4 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: status not confirmed, as of the sponsor's last update on 20 Nov 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 Switzerland. 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. Some participants in this study may receive a placebo. 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?
Improvement in specific motor task (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Nov 2020.