A Randomized Controlled Trial of Cervical Electrical Stimulation for Parkinson's Disease

JRCT ID: jRCTs062240041

Registered date:29/07/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Parkinson's Disease
• Date of first enrollment: 29/07/2024
• Target sample size: 60
• Study type: Interventional
• Intervention(s): Using a low-frequency pulse wave stimulation device or an interference wave stimulation device

Outcome(s)

Primary Outcome

1 Comparison with the control group, improvement in the proportion of subjects with a normal cough reflex in the 1% citric acid cough test (defined as five or more coughs per minute) at the end of the two-week intervention with interference wave stimulation
2 Comparison with the control group, improvement in the proportion of subjects with a normal cough reflex in the 1% citric acid cough test (defined as five or more coughs per minute) at the end of the two-week intervention with low-frequency pulse wave stimulation

Secondary Outcome

1 Superiority in the proportion of subjects with a normal cough reflex in the 1% citric acid cough test at the end of the two-week intervention, comparing the GentleStim group and the Ito Postim group.
2 Tolerability (continuation rate of device use). The proportion of patients who were able to complete 12 or more days out of the 14-day intervention.
3 The proportion of patients with a Penetration-Aspiration Scale score of 1 or 2 in the swallowing fluoroscopy at the end of the two-week intervention, comparing the GentleStim group and the Ito Postim group to the control group.
*The Penetration-Aspiration Scale is an 8-level scale (with 8 being the most severe), where 1 indicates no entry into the larynx or airway, and 2 indicates laryngeal entry above the vocal cords with no residue in the larynx.
4 Changes in bolus passage as assessed by swallowing fluoroscopy phase analysis at the end of the two-week intervention, comparing the GentleStim group and the Ito Postim group to the control group.
5 The proportion of patients with normal swallowing status (FOIS scale, EAT-10) at the end of the two-week intervention, comparing the GentleStim group and the Ito Postim group to the control group.
*FOIS scale: 7 (full score), EAT-10: 2 points or less are considered normal.
6 Changes in multichannel electromyography findings at the end of the two-week intervention, comparing the GentleStim group and the Ito Postim group to the control group.
7 Changes in tongue pressure values at the end of the two-week intervention, comparing the GentleStim group and the Ito Postim group to the control group.
8 Changes in swallowing sounds assessed by electronic auscultation at the end of the two-week intervention, comparing the GentleStim group and the Ito Postim group to the control group.
9 Changes in salivary substance P at the end of the two-week intervention, comparing the GentleStim group and the Ito Postim group to the control group.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 85age old
• Gender: Both

Include criteria

1. Patients diagnosed with Parkinson's disease as clinically probable or clinically established according to the Movement Disorder Society criteria and who have symptoms of dysphagia.
2. Patients at Hoehn-Yahr stage 2-4 at the time of enrollment.
3. Patients whose prescription for levodopa has not been changed for at least one month prior to enrollment.
4. Patients who are 18 years old or older and 85 years old or younger at the time of consent.
5. Patients who can provide written consent for participation in this study.

Exclude criteria

1. Patients with specific implanted electronic devices such as pacemakers.
2. Patients with a high possibility of hemorrhagic or thrombotic disorders.
3. Patients currently suffering from malignant tumors.
4. Pregnant women or those wishing to become pregnant.
5. Patients currently suffering from head and neck cancer, or with a history of such cancer or surgery.
6. Patients with febrile diseases, infectious diseases, or acute painful diseases.
7. Patients with edema, injury, ischemic tissue, venous engorgement, or metal implants in the skin or subcutaneous tissue of the neck.
8. Patients who have experienced allergic reactions, constipation, or other health issues after taking barium.
9. Any other individuals deemed inappropriate by the principal investigator or sub-investigator.

Related Information

• Primary Sponsor: Maruyama Hirofumi
• Source(s) of Monetary Support: Grant-in-aid for scientific research