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

NCT05478057 | Unknown

• 1 other identifier: 202102465A3A0
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Parkinson Disease

Keywords

speech disturbance; transcranial magnetic stimulation

Outcome Measures

Primary Outcomes (3)

• Change of speech performance from baseline in experiment 1

  1. sustained phonation of /a/ for as long and steady as possible in one breath 2. fast pa-/ta-/ka- repetition at least nine times in one breath 3. reading a standardized paragraph composed of 80 words as clear and fast as possible

  Baseline ((1) before rTMS), (2) immediately after rTMS

• Change of speech performance from baseline in experiment 2

  1. sustained phonation of /a/ for as long and steady as possible in one breath 2. fast pa-/ta-/ka- repetition at least nine times in one breath 3. reading a standardized paragraph composed of 80 words as clear and fast as possible

  Baseline ((1) before rTMS), (2) within 24 hours after 10 times of rTMS (3) 8 weeks later after 10 times of rTMS

• 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

  Baseline ((1) before rTMS), (2) within 24 hours after 10 times of rTMS

Study Arms (4)

PD patients with speech disturbance treated with 10 Hz rTMS

EXPERIMENTAL

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

PD patients with speech disturbance treated with sham rTMS

SHAM COMPARATOR

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

PD patients without speech disturbance treated with 10 Hz rTMS

EXPERIMENTAL

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

PD patients without speech disturbance with sham rTMS

SHAM COMPARATOR

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

Interventions

"MAGSTIM" Repetitive transcranial magnetic stimulator (rTMS) system DEVICE

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.

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

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• pregnancy or possibility of pregnancy
• history of seizure
• family history of epilepsy
• metals in any part of the body.
• Experiment 2
• 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.
• dementia
• the history of stroke, brain lesion, other central nervous system diseases
• the contraindication of TMS which described above
• any contraindication of MRI

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

MeSH Terms

Conditions

Parkinson Disease; Speech Disorders

Interventions

Transcranial Magnetic Stimulation; Drug Delivery Systems

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics; Drug Therapy

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

Study Record Dates

• First Submitted: July 11, 2022
• First Posted: July 28, 2022
• Study Start: August 1, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 28, 2022

Record last verified: 2022-07