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

Sponsor
Chang Gung Memorial Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05478057
Collaborator
(none)
60
4
41

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: "MAGSTIM" Repetitive transcranial magnetic stimulator (rTMS) system
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Supplementary Motor Area is a Potential Target for Speech Disturbance in Parkinson Disease
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Dec 31, 2025
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: PD patients with speech disturbance treated with 10 Hz rTMS

Device: "MAGSTIM" Repetitive transcranial magnetic stimulator (rTMS) system
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.

Sham Comparator: PD patients with speech disturbance treated with sham rTMS

Device: "MAGSTIM" Repetitive transcranial magnetic stimulator (rTMS) system
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.

Experimental: PD patients without speech disturbance treated with 10 Hz rTMS

Device: "MAGSTIM" Repetitive transcranial magnetic stimulator (rTMS) system
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.

Sham Comparator: PD patients without speech disturbance with sham rTMS

Device: "MAGSTIM" Repetitive transcranial magnetic stimulator (rTMS) system
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.

Outcome Measures

Primary Outcome Measures

  1. Change of speech performance from baseline in experiment 1 [Baseline ((1) before rTMS), (2) immediately after rTMS]

    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

  2. Change of speech performance from baseline in experiment 2 [Baseline ((1) before rTMS), (2) within 24 hours after 10 times of rTMS (3) 8 weeks later after 10 times of rTMS]

    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

  3. Change of functional connectivity from baseline in experiment 2 [Baseline ((1) before rTMS), (2) within 24 hours after 10 times of rTMS]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Chang Gung Memorial Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT05478057
Other Study ID Numbers:
  • 202102465A3A0
First Posted:
Jul 28, 2022
Last Update Posted:
Jul 28, 2022
Last Verified:
Jul 1, 2022
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
Keywords provided by Chang Gung Memorial Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 28, 2022