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Supplementary Motor Area is a Potential Target for Speech Disturbance in Parkinson Disease

Primary Purpose

Parkinson Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
"MAGSTIM" Repetitive transcranial magnetic stimulator (rTMS) system
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring speech disturbance, transcranial magnetic stimulation

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Experiment 1

Inclusion Criteria:

  • right-handed healthy adult volunteers who understand and agree on the informed consent of the study

Exclusion Criteria:

  • pregnancy or possibility of pregnancy
  • history of seizure
  • family history of epilepsy
  • metals in any part of the body.

Experiment 2

Inclusion Criteria:

  • PD patients with speech disturbance who understand and agree on the informed consent of the study. The speech item scored 2 or 3 in the unified Parkinson's disease rating scale (UPDRS) part III.

Exclusion Criteria:

  • dementia
  • the history of stroke, brain lesion, other central nervous system diseases
  • the contraindication of TMS which described above
  • any contraindication of MRI

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Sham Comparator

    Experimental

    Sham Comparator

    Arm Label

    PD patients with speech disturbance treated with 10 Hz rTMS

    PD patients with speech disturbance treated with sham rTMS

    PD patients without speech disturbance treated with 10 Hz rTMS

    PD patients without speech disturbance with sham rTMS

    Arm Description

    Outcomes

    Primary Outcome Measures

    Change of speech performance from baseline in experiment 1
    sustained phonation of /a/ for as long and steady as possible in one breath fast pa-/ta-/ka- repetition at least nine times in one breath reading a standardized paragraph composed of 80 words as clear and fast as possible
    Change of speech performance from baseline in experiment 2
    sustained phonation of /a/ for as long and steady as possible in one breath fast pa-/ta-/ka- repetition at least nine times in one breath reading a standardized paragraph composed of 80 words as clear and fast as possible
    Change of functional connectivity from baseline in experiment 2
    use rs-fMRI to compare the functional connectivity between PD patients with and without speech disturbance and the changes of connectivity after rTMS over SMA

    Secondary Outcome Measures

    Full Information

    First Posted
    July 11, 2022
    Last Updated
    July 27, 2022
    Sponsor
    Chang Gung Memorial Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05478057
    Brief Title
    Supplementary Motor Area is a Potential Target for Speech Disturbance in Parkinson Disease
    Official Title
    Supplementary Motor Area is a Potential Target for Speech Disturbance in Parkinson Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 1, 2022 (Anticipated)
    Primary Completion Date
    December 31, 2025 (Anticipated)
    Study Completion Date
    December 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Chang Gung Memorial Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    Brief Summary
    Speech disturbance is common in patients with Parkinson disease. Pharmacotherapy improves motor symptoms but has inconsistent effects on speech disturbance in PD patients. Transcranial magnetic stimulation (TMS) is a safe and non-invasive tool used for brain stimulation. Repetitive transcranial magnetic stimulation (rTMS) has positive effects on motor function of PD. Yet, its effect on speech disturbance seems to be inconclusive. Previous rTMS studies mainly focused on the primary motor cortex for PD speech disturbance. Nevertheless, we think supplementary motor area (SMA) may be a better target. Speech disturbance in PD may be associated with basal ganglia-thalamocortical motor circuits and SMA involves in the cortex part. In addition, neuroimaging studies showed that SMA were under-activation in PD patients. Therefore, we conduct this 3-year study including two experiments. The aim of the study is to determine if rTMS over SMA can improve the speech function of PD patients and change the functional connectivity of speech pathway in the brain. This will be the first study to investigate the effect of rTMS over SMA on speech.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Parkinson Disease
    Keywords
    speech disturbance, transcranial magnetic stimulation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    PD patients with speech disturbance treated with 10 Hz rTMS
    Arm Type
    Experimental
    Arm Title
    PD patients with speech disturbance treated with sham rTMS
    Arm Type
    Sham Comparator
    Arm Title
    PD patients without speech disturbance treated with 10 Hz rTMS
    Arm Type
    Experimental
    Arm Title
    PD patients without speech disturbance with sham rTMS
    Arm Type
    Sham Comparator
    Intervention Type
    Device
    Intervention Name(s)
    "MAGSTIM" Repetitive transcranial magnetic stimulator (rTMS) system
    Intervention Description
    we plan to recruit 60 patients with Parkinson disease, comprising 30 patients with speech disturbance and 30 age- and sex-match patients without speech disturbance. Each group of patients will be randomly divided into sham stimulation or rTMS. A total of 10 rTMS sessions will be applied in 2 weeks. The effect of rTMS will be evaluated via the changes of speech performance and functional connectivity which was analyzed from resting-state functional magnetic resonance imaging.
    Primary Outcome Measure Information:
    Title
    Change of speech performance from baseline in experiment 1
    Description
    sustained phonation of /a/ for as long and steady as possible in one breath fast pa-/ta-/ka- repetition at least nine times in one breath reading a standardized paragraph composed of 80 words as clear and fast as possible
    Time Frame
    Baseline ((1) before rTMS), (2) immediately after rTMS
    Title
    Change of speech performance from baseline in experiment 2
    Description
    sustained phonation of /a/ for as long and steady as possible in one breath fast pa-/ta-/ka- repetition at least nine times in one breath reading a standardized paragraph composed of 80 words as clear and fast as possible
    Time Frame
    Baseline ((1) before rTMS), (2) within 24 hours after 10 times of rTMS (3) 8 weeks later after 10 times of rTMS
    Title
    Change of functional connectivity from baseline in experiment 2
    Description
    use rs-fMRI to compare the functional connectivity between PD patients with and without speech disturbance and the changes of connectivity after rTMS over SMA
    Time Frame
    Baseline ((1) before rTMS), (2) within 24 hours after 10 times of rTMS

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Experiment 1 Inclusion Criteria: right-handed healthy adult volunteers who understand and agree on the informed consent of the study Exclusion Criteria: pregnancy or possibility of pregnancy history of seizure family history of epilepsy metals in any part of the body. Experiment 2 Inclusion Criteria: PD patients with speech disturbance who understand and agree on the informed consent of the study. The speech item scored 2 or 3 in the unified Parkinson's disease rating scale (UPDRS) part III. Exclusion Criteria: dementia the history of stroke, brain lesion, other central nervous system diseases the contraindication of TMS which described above any contraindication of MRI

    12. IPD Sharing Statement

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    Supplementary Motor Area is a Potential Target for Speech Disturbance in Parkinson Disease

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