- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT04442971
Skuteczność muzykoterapii na poziomie świadomości
Badanie skuteczności muzykoterapii na poziomie świadomości pacjentów wczesnej rehabilitacji neurologicznej
It is known that even in patients with severe disorders of consciousness (DOC), the perception of known stimuli triggers emotional reactions that can be interpreted as an expression of a residual function of consciousness. Music therapy has a long tradition in neurological rehabilitation. Frequently, active therapies with own music making and singing are implemented in clinical settings. In DOC patients, it is more likely to use passive music listening. However, findings on effectiveness are limited, as only a few studies have systematically investigated the effects of music therapy in this population. Therefore, the investigators want to investigate the effectiveness of passive listening to preferred music on the level of consciousness.
Przegląd badań
Status
Szczegółowy opis
Due to continuous improvements in acute medical care, the number of patients surviving severe brain damage has increased over the past decades. While some patients improve significantly during the first days after the injury, other patients remain in altered states of consciousness (i.e. coma, unresponsive wakefulness syndrome or minimally conscious state). In patients with disorders of consciousness (DOC), the auditory modality is preferably examined because the responsiveness within the motor and visual modality is often difficult to assess or impaired. Music is a special type of auditory stimulation that can be of particular benefit in DOC patients. The positive effects of music are attributed to the restoration of specific brain networks that are necessary for processing sensory inputs, as well as the emotional aspects of music, which can increase arousal and activate the reward system. Previous studies have shown that music, including passive listening to music, is associated with psychological and physical changes in both healthy and clinical populations. For example, listening to preferred music can reduce pain and anxiety and the need for sedation in different patient groups.
Music therapy has a long tradition in neurological rehabilitation. In DOC patients, passive listening to music is used (in contrast to active therapies used in fully conscious patients). Efficacy results are inconsistent, however, since only a few studies have systematically investigated the effects of music therapy. In previous investigations, either the sample size is very small or no control conditions have been used. A study that met both quality criteria was published by Sun & Chen in 2015. The authors compared two groups: while the music group (n = 20) listened to their favorite music for 15 to 30 minutes three times a day for a period of four weeks, the control group received no stimulation. Although the GCS values increased significantly in both groups, the music group showed a significantly stronger improvement in the level of consciousness. Based on this study, the present study wants to compare the effectiveness of passive listening to music with two control conditions (alternative auditory stimulation and no auditory stimulation) in early neurological rehabilitation patients.
It is a prospective, double-blind, controlled and randomized intervention study that is carried out monocentrically. Over a period of 24 months, 66 patients undergoing early neurological and neurosurgical rehabilitation after severe brain damage are included. For the individual patient, the study duration is a maximum of 38 days (preliminary phase: 3-7 days; intervention phase: 28 days; follow-up phase: 1-3 days). Patients are randomly assigned to one of three study arms (1. Musical stimulation; 2. Alternative auditory stimulation, 3. No auditory stimulation). In the preliminary phase (days 1 to 7), a native MRI (without contrast agent) and a CRS-R assessment are performed. In addition, there is a neurophysiological examination in which evoked potentials are recorded. In the subsequent main phase, the intervention takes place: Over a period of 28 days, the study participants wear headphones for 30 minutes a day, through which they are presented with preferred music (experimental arm), an audio book (comparative arm) or silence (control arm). In the main phase, a CRS-R test is carried out weekly to record the current state of consciousness. In the follow-up phase (1 to 3 days), the (native) MRI examination, the CRS-R assessment and the neurophysiological examination are repeated. The primary outcome measure is an improvement of the level of consciousness, measured with the Coma-Recovery-Scale-Revised (CRS-R).
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Hessisch Oldendorf, Niemcy, 31840
- BDH-Clinic Hessisch Oldendorf
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- early neurological rehabilitation (phase B)
- traumatic brain injury
- disorder of consciousness (coma, UWS, MCS)
- at minimum two weeks after disease onset
- admission to intensive care unit
- written consent from the patient's legal representative
- Exclusion of pregnancy
Exclusion Criteria:
- insufficient cardiorespiratory stability
- fractures or severe infratentorial brain injuries leading to impaired auditory evoked potentials
- previous brain damage
- Known mental disorders (dementia, depression)
- hearing loss or deafness in one or two ears
- wounds that do not allow you to wear headphones
- colonization with multi-resistant pathogens
- MRI contraindications
- claustrophobia
- weight>120 kg
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Poczwórny
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: Music Stimulation
Patients preferred music is presented via headphones. |
Patients wear headphones for 30 minutes/day over a period of four weeks and listen to their preferred music. |
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Aktywny komparator: Alternative Auditory Stimulation
An audio book is presented via headphones. |
Patients wear headphones for 30 minutes/day over a period of four weeks and listen to an audio book. |
|
Pozorny komparator: No Auditory Stimulation
Silence is presented via headphones. |
Patients wear headphones for 30 minutes/day over a period of four weeks and hear silence. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in level of consciousness
Ramy czasowe: 4 weeks
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Level of consciousness is measured with the Coma-Recovery-Scale-Revised (Range: 0 to 23) before and after treatment. |
4 weeks
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in connectivity within the default mode network
Ramy czasowe: 4 weeks
|
Patients undergo a MRI scan before and after intervention. Each MRI scan has a duration of 30 minutes. Functional and structural sequences are measured. The resting-state scan (important for the assessment of the default mode network) has a duration of eight minutes and is performed without external stimulation. |
4 weeks
|
Współpracownicy i badacze
Sponsor
Śledczy
- Dyrektor Studium: Jens D Rollnik, MD, BDH-Clinic Hessisch Oldendorf
- Główny śledczy: Melanie Boltzmann, PhD, BDH-Clinic Hessisch Oldendorf
Publikacje i pomocne linki
Publikacje ogólne
- Kotchoubey B, Pavlov YG, Kleber B. Music in Research and Rehabilitation of Disorders of Consciousness: Psychological and Neurophysiological Foundations. Front Psychol. 2015 Nov 27;6:1763. doi: 10.3389/fpsyg.2015.01763. eCollection 2015.
- Perrin F, Castro M, Tillmann B, Luaute J. Promoting the use of personally relevant stimuli for investigating patients with disorders of consciousness. Front Psychol. 2015 Jul 30;6:1102. doi: 10.3389/fpsyg.2015.01102. eCollection 2015.
- Chlan LL, Weinert CR, Heiderscheit A, Tracy MF, Skaar DJ, Guttormson JL, Savik K. Effects of patient-directed music intervention on anxiety and sedative exposure in critically ill patients receiving mechanical ventilatory support: a randomized clinical trial. JAMA. 2013 Jun 12;309(22):2335-44. doi: 10.1001/jama.2013.5670.
- Sun J, Chen W. Music therapy for coma patients: preliminary results. Eur Rev Med Pharmacol Sci. 2015 Apr;19(7):1209-18.
- Hole J, Hirsch M, Ball E, Meads C. Music as an aid for postoperative recovery in adults: a systematic review and meta-analysis. Lancet. 2015 Oct 24;386(10004):1659-71. doi: 10.1016/S0140-6736(15)60169-6. Epub 2015 Aug 12.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Objawy neurologiczne
- Choroby mózgu
- Choroby ośrodkowego układu nerwowego
- Zaburzenia psychiczne
- Rany i urazy
- Manifestacje neurobehawioralne
- Zaburzenia neurokognitywne
- Uraz czaszkowo-mózgowy
- Uraz, układ nerwowy
- Urazy mózgu
- Stany patologiczne, oznaki i objawy
- Objawy i symptomy
- Urazy mózgu, traumatyczne
- Choroby Układu Nerwowego
- Zaburzenia świadomości
Inne numery identyfikacyjne badania
- DOC-MT
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
All IPD that underlie results in a publication.
Ramy czasowe udostępniania IPD
Period of availability begins when results are published, at the earliest in Dec 2022
Kryteria dostępu do udostępniania IPD
IPD can be obtained from the principal investigator upon reasonable request.
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
- SOK ROŚLINNY
- ICF
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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