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OpenTrials
Completed

NCT Number: NCT04929795

Effects of Music Beat on Motor Function in Individuals At Risk for Psychotic Onset and Schizophrenia Patients

The purpose of this project is to investigate whether a 3-week training program involving music beat (serving as a type of rhythmic auditory stimulation) reduces the severity of bradykinesia and dyskinesia in at-risk individuals and schizophrenia patients. It is hypothesized that the program is effective in reducing the severity of bradykinesia and dyskinesia in at-risk individuals and schizophrenia patients.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

For at-risk participants:

Inclusion criteria

  • A score of or above 9 in the Chinese version of the 16-item Prodromal Questionnaire (CPQ-16), or a score of or above 8.18 in the Chinese version of Community Assessment of Psychic Experiences with 15 items (CAPE-C15), or a score of or above 17 in Schizotypal Personality Questionnaire-Brief (SPQ-B);
  • an age of 13 years or above;
  • score > 60 in The Chinese version of Edinburgh Handedness Inventory (CH-EBI) to ensure right handedness; and
  • score ≥ 22 in Montreal Cognitive Assessment Hong Kong Version (HK-MoCA) to ensure no serious cognitive deficits so that they can understand instructions.

Exclusion criteria

  • psychiatric diagnosis by self-report;
  • cardiovascular, neurological, muscular or orthopedic diseases that may affect hand movements;
  • taking psychiatric medications;
  • substance abuse; and
  • being pregnant.

For schizophrenia participants:

Inclusion criteria

  • a diagnosis of schizophrenia without other psychiatric diseases;
  • the age ≥ 18 years;
  • score > 60 in CH-EBI to ensure right handedness; and
  • score ≥ 22 in HK-MoCA to ensure no serious cognitive deficits so that they can understand instructions.

Exclusion criteria

  • cardiovascular, neurological, muscular or orthopedic diseases that may affect hand movements;
  • substance abuse; and
  • being pregnant.

Treatment and study plan

Rhythmic Auditory Stimulation (RAS)

Behavioral

The song named 'Sign of The Times' is played and recorded by the research personnel beforehand. The beat of the song will serve as RAS. The computer software "Audacity" will be used to adjust tempi of RAS. Before intervention, the participant is required to execute the movement task without the aid of RAS as quickly as possible for 30 seconds, so that we obtain his/her baseline movement tempo. For each 40-minute training session in the first training week, three RAS tempi will be provided for the first, second, and last 10 minutes with a five-minute break in between: normal (100% of the baseline tempo), quick (105% of the baseline tempo), and fast (110% of the baseline tempo). With each training week, the three RAS tempi will be increased by 5%. Participants in the experimental groups are required to use their right hand to pick up beads from source bowls to the target bowl when listening to the song. The 3-week intervention program will include 21 40-minute daily training sessions.

no RAS

Behavioral

The training protocol will be the same as that used in the experimental group except the lack of RAS during execution of the movement task.

Primary outcomes

  1. Motion analysis by using an eight-camera motion capture system (VICON; Oxford Metrics Group, Oxford, UK)

    Time frame: Within one week right before the 1st session of the intervention

    normalized movement time (representing severity of bradykinesia). Unit: second/mm

  2. Motion analysis by using an eight-camera motion capture system (VICON; Oxford Metrics Group, Oxford, UK)

    Time frame: Within one week right after the last session of the intervention

    normalized movement time (representing severity of bradykinesia). Unit: second/mm

  3. Motion analysis by using an eight-camera motion capture system (VICON; Oxford Metrics Group, Oxford, UK)

    Time frame: Within one week right before the 1st session of the intervention

    normalized number of movement units (representing severity of dyskinesia). Unit: units/mm

  4. Motion analysis by using an eight-camera motion capture system (VICON; Oxford Metrics Group, Oxford, UK)

    Time frame: Within one week right after the last session of the intervention

    normalized number of movement units (representing severity of dyskinesia). Unit: units/mm

Sponsors and collaborators

Lead sponsor

Dr WANG Shumei

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 18, 2021
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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