Parkinson's SyndromeNCT06370195
Effect of Stellate Ganglion Block on Drooling in Parkinson's Syndrome
A study testing Comprehensive rehabilitation, Stellate ganglion block and Lidocaine hydrochloride in people with Parkinson's Syndrome, run by Babujinaya Cela.
Trial summary
This is a randomized controlled study, including dysphagic patients with Parkinson's syndrome who were received in the department of rehabilitation medicine. All patients are randomly allocated to the observation group or the control group. Both groups are provided with comprehensive rehabilitation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Syndrome
- What is being tested?
- Comprehensive rehabilitation, Stellate ganglion block and Lidocaine hydrochloride
- Type of treatment
- Injection or infusion, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Apr 2024to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years.
- Meeting the diagnostic criteria for Parkinson's disease developed by the Neurology Branch of the Chinese Medical Association in 2006.
- Diagnosed with dysphagia confirmed by the video fluoroscopic swallowing study.
- Stable vital signs, conscious, able to cooperate with assessment and treatment.
Who cannot join
- Dysphagia possibly caused by other reasons, such as cerebrovascular disease, trauma, neuromuscular diseases, malignant diseases of the pharynx and larynx, and digestive tract diseases.
- History of mental diseases or use of antipsychotics.
- Complicated with cognitive impairment or consciousness dysfunction.
- Simultaneously suffering from severe liver, kidney failure, tumors, or hematological diseases.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Stellate Ganglion Block on Drooling in Parkinson's Syndrome: A Randomized Controlled Study
This is a randomized controlled study, including dysphagic patients with Parkinson's syndrome who were received in the department of rehabilitation medicine. All patients are randomly allocated to the observation group or the control group. Both groups are provided with comprehensive rehabilitation. Besides, the observation group additionally undergoes the stellate ganglion block. At admission and after 10-day treatment, Functional Oral Intake Scale, Drooling amount, depression are assessed.
Read the detailed description
Palliation of dysphagia in patients with Parkinson's syndrome continues to be a challenge.
This is a randomized controlled study, including dysphagic patients with Parkinson's syndrome who were received in the department of rehabilitation medicine. All patients are randomly allocated to the observation group or the control group. Both groups are provided with comprehensive rehabilitation. Besides, the observation group additionally undergoes the stellate ganglion block. At admission and after 10-day treatment, Functional Oral Intake Scale, Drooling amount, depression are assessed.
- Conditions
- Parkinson's Syndrome
- Being tested
- Comprehensive rehabilitation, Stellate ganglion block, Lidocaine hydrochloride, Placebo injection
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive rehabilitationBehavioural
The study lasted 10d for each patient. During the treatment, All the participants were provided with the rehabilitation therapy, which included routine rehabilitation, cognitive training, swallowing function training.
Stellate ganglion blockProcedure or surgery
Based on the invention above, the patients in the observation group were provided with Stellate ganglion block , using 1.5ml of 2% Lidocaine hydrochloride (1ml: 0.5mg) and 500ug of Vitamin B12 (1ml: 0.5g). The percutaneous approach via the paratracheal route was used for Stellate ganglion block . The operator stood on the side of the block, instructed the patient to lie supine with a thin pillow placed below the shoulders, and tilted the head 45° towards the blocked side, fully exposing the neck. Then, routine disinfection of the neck skin was performed. The puncture site was located 2.5 cm above the sternoclavicular joint and 1.5 cm lateral to the midline of the neck.
Lidocaine hydrochlorideDrug
Based on the invention above, the patients in the observation group were provided with Stellate ganglion block , using 1.5ml of 2% Lidocaine hydrochloride (1ml: 0.5mg) and 500ug of Vitamin B12 (1ml: 0.5g). The percutaneous approach via the paratracheal route was used for Stellate ganglion block . The operator stood on the side of the block, instructed the patient to lie supine with a thin pillow placed below the shoulders, and tilted the head 45° towards the blocked side, fully exposing the neck. Then, routine disinfection of the neck skin was performed. The puncture site was located 2.5 cm above the sternoclavicular joint and 1.5 cm lateral to the midline of the neck.
Placebo injectionProcedure or surgery
1 milliliter of normal saline will be used for injection. The percutaneous approach via the paratracheal route was used for Stellate ganglion block . The operator stood on the side of the block, instructed the patient to lie supine with a thin pillow placed below the shoulders, and tilted the head 45° towards the blocked side, fully exposing the neck. Then, routine disinfection of the neck skin was performed. The puncture site was located 2.5 cm above the sternoclavicular joint and 1.5 cm lateral to the midline of the neck.
| Study group | Role | What they receive |
|---|---|---|
| Comprehensive rehabilitation+Stellate ganglion block | Experimental | Patients enrolled are firstly numbered for privacy with software and divided into the observation group and the control group with. Additionally, the staffs involved in assessment would not participate in the intervention of the study. The treatment lasts 10 days. Receives: Behavioral: Comprehensive rehabilitation; Procedure: Stellate ganglion block; Drug: Lidocaine hydrochloride |
| Comparator: Comprehensive rehabilitation+placebo | Placebo comparator | Patients enrolled are firstly numbered for privacy with software and divided into the observation group and the control group with. Additionally, the staffs involved in assessment would not participate in the intervention of the study. The treatment lasts 10 days. Receives: Behavioral: Comprehensive rehabilitation; Procedure: Placebo injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drooling amount
All participants' saliva was collected within 5 minutes into a cup, followed by the comparison of saliva quantity, composition 1 hour before noon, the amount will be recorded.
Measured: day 1 and day 10
Secondary outcomes (2)
Modified Barthel Index
the activities of daily living of patients will be assessed using the modified Barthel Index . The scale includes 10 items such as feeding, bathing, walking, dressing. Each item is rated on a 4-point scale based on the level of assistance required, with a total score of 100 points. There is a positive correlation between activities of daily living and the final score.
Measured: day 1 and day 10
Patient Health Questionnaire-9
Patient Health Questionnaire-9 (PHQ-9) is a commonly used depression screening tool consisting of 9 items, designed to assess the severity of individual depressive symptoms. Each item is rated from 0 (not at all) to 3 (nearly every day) based on how the individual has been feeling over the past two weeks.
The total score ranges from 0 to 27, and the severity of depressive symptoms is assessed as follows:
0-4: Minimal depression 5-9: Mild depression 10-14: Moderate depression 15-19: Moderately severe depression 20 and above: Severe depression When assessing the severity of depressive symptoms, a higher total score indicates more severe symptoms, while a lower total score indicates milder symptoms.
Measured: day 1 and day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study startApr 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Babujinaya Cela
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Babujinaya Cela, Buraidah Central Hospital
- Investigators
- Louis Wi, Study director, Site Coordinator of United Medical Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06370195
- Sponsor's protocol ID
- SGB-Liuxian
- Status last verified
- Apr 2024
- First submitted
- 13 Apr 2024
- Last updated
- 17 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Stellate Ganglion Block on Drooling in Parkinson's Syndrome: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06370195
- Acronym / sponsor ID
- SGB-Liuxian
- Conditions
- Parkinson's Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Babujinaya CelaOther government
- Study start
- Apr 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 17 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized controlled study, including dysphagic patients with Parkinson's syndrome who were received in the department of rehabilitation medicine. All patients are randomly allocated to the observation group or the control group. Both groups are provided with comprehensive rehabilitation. Besides, the observation group additionally undergoes the stellate ganglion block. At admission and after 10-day treatment, Functional Oral Intake Scale, Drooling amount, depression are assessed.
Detailed description
Palliation of dysphagia in patients with Parkinson's syndrome continues to be a challenge.
This is a randomized controlled study, including dysphagic patients with Parkinson's syndrome who were received in the department of rehabilitation medicine. All patients are randomly allocated to the observation group or the control group. Both groups are provided with comprehensive rehabilitation. Besides, the observation group additionally undergoes the stellate ganglion block. At admission and after 10-day treatment, Functional Oral Intake Scale, Drooling amount, depression are assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comprehensive rehabilitation+Stellate ganglion block | Experimental | Behavioral: Comprehensive rehabilitation, Procedure: Stellate ganglion block, Drug: Lidocaine hydrochloridePatients enrolled are firstly numbered for privacy with software and divided into the observation group and the control group with. Additionally, the staffs involved in assessment would not participate in the intervention of the study. The treatment lasts 10 days. |
| Comparator: Comprehensive rehabilitation+placebo | Placebo comparator | Behavioral: Comprehensive rehabilitation, Procedure: Placebo injectionPatients enrolled are firstly numbered for privacy with software and divided into the observation group and the control group with. Additionally, the staffs involved in assessment would not participate in the intervention of the study. The treatment lasts 10 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >18 years.
- Meeting the diagnostic criteria for Parkinson's disease developed by the Neurology Branch of the Chinese Medical Association in 2006.
- Diagnosed with dysphagia confirmed by the video fluoroscopic swallowing study.
- Stable vital signs, conscious, able to cooperate with assessment and treatment.
Key exclusion criteria (4 listed)
- Dysphagia possibly caused by other reasons, such as cerebrovascular disease, trauma, neuromuscular diseases, malignant diseases of the pharynx and larynx, and digestive tract diseases.
- History of mental diseases or use of antipsychotics.
- Complicated with cognitive impairment or consciousness dysfunction.
- Simultaneously suffering from severe liver, kidney failure, tumors, or hematological diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comprehensive rehabilitationThe study lasted 10d for each patient. During the treatment, All the participants were provided with the rehabilitation therapy, which included routine rehabilitation, cognitive training, swallowing function training. | Behavioural | Comparator: Comprehensive rehabilitation+placebo, Comprehensive rehabilitation+Stellate ganglion block |
| Stellate ganglion blockBased on the invention above, the patients in the observation group were provided with Stellate ganglion block , using 1.5ml of 2% Lidocaine hydrochloride (1ml: 0.5mg) and 500ug of Vitamin B12 (1ml: 0.5g). The percutaneous approach via the paratracheal route was used for Stellate ganglion block . The operator stood on the side of the block, instructed the patient to lie supine with a thin pillow placed below the shoulders, and tilted the head 45° towards the blocked side, fully exposing the neck. Then, routine disinfection of the neck skin was performed. The puncture site was located 2.5 cm above the sternoclavicular joint and 1.5 cm lateral to the midline of the neck. | Procedure or surgery | Comprehensive rehabilitation+Stellate ganglion block |
| Lidocaine hydrochlorideBased on the invention above, the patients in the observation group were provided with Stellate ganglion block , using 1.5ml of 2% Lidocaine hydrochloride (1ml: 0.5mg) and 500ug of Vitamin B12 (1ml: 0.5g). The percutaneous approach via the paratracheal route was used for Stellate ganglion block . The operator stood on the side of the block, instructed the patient to lie supine with a thin pillow placed below the shoulders, and tilted the head 45° towards the blocked side, fully exposing the neck. Then, routine disinfection of the neck skin was performed. The puncture site was located 2.5 cm above the sternoclavicular joint and 1.5 cm lateral to the midline of the neck. | Drug | Comprehensive rehabilitation+Stellate ganglion block |
| Placebo injection1 milliliter of normal saline will be used for injection. The percutaneous approach via the paratracheal route was used for Stellate ganglion block . The operator stood on the side of the block, instructed the patient to lie supine with a thin pillow placed below the shoulders, and tilted the head 45° towards the blocked side, fully exposing the neck. Then, routine disinfection of the neck skin was performed. The puncture site was located 2.5 cm above the sternoclavicular joint and 1.5 cm lateral to the midline of the neck. | Procedure or surgery | Comparator: Comprehensive rehabilitation+placebo |
Primary outcome
Drooling amount
Time frame: day 1 and day 10
All participants' saliva was collected within 5 minutes into a cup, followed by the comparison of saliva quantity, composition 1 hour before noon, the amount will be recorded.
2 secondary outcomes
Modified Barthel Index
Time frame: day 1 and day 10
Patient Health Questionnaire-9
Time frame: day 1 and day 10
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louis Wi study director
Site Coordinator of United Medical Group
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive rehabilitation, Stellate ganglion block and Lidocaine hydrochloride in people with Parkinson's Syndrome, run by Babujinaya Cela.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laviena Ce (15422548954, linchuangzhuce@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drooling amount (time frame: day 1 and day 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.