Acoustic Cueing During Slow-wave Sleep as a Measure to Improve Motor Rehabilitation Outcome in Stroke Patients

NCT03684603 | Unknown

• 1 other identifier: 2017-00199
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Stroke

Keywords

Sleep; Acoustic Cueing

Outcome Measures

Primary Outcomes (1)

• 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.

  5 days

Secondary Outcomes (2)

• Correlation of motor learning curve and time of sleep cueing

  5 days

• Improvement in generalized motor rehabilitation outcome

  5 days

Study Arms (2)

Acoustic cueing

ACTIVE COMPARATOR

The melody will be played during training and during slow wave sleep.

Behavioral: melody during motor training and slow wave sleep

Control

SHAM COMPARATOR

The melody will be played during training.

Behavioral: melody only during motor training

Interventions

melody during motor training and slow wave sleep BEHAVIORAL

sequence of tones which are presented to the patient using earphones

Acoustic cueing

melody only during motor training BEHAVIORAL

sequence of tones which are presented to the patient using earphones

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Christian Baumann: lead
• Cereneo AG: collaborator

Study Sites (1)

University Hospital Zurich

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Stroke

Interventions

Sleep, Slow-Wave

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sleep Stages; Sleep; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Christian Baumann, MD

  University Hospital Zurich, Clinic of Neurology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 6, 2018
• First Posted: September 25, 2018
• Study Start: November 1, 2017
• Primary Completion: June 1, 2020
• Study Completion: April 1, 2021
• Last Updated: November 20, 2020

Record last verified: 2020-11

Locations

CH (1)