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
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring speech disturbance, transcranial magnetic stimulation
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
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
NCT ID
NCT05478057
First Posted
July 11, 2022
Last Updated
July 27, 2022
Sponsor
Chang Gung Memorial Hospital
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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