AzTrials
AzTrials

Parkinson DiseaseNCT04361188

UPDRS-III Comparisons of DBS for PD Between Patients Receiving MAC and AAA Anesthesia

A study testing MAC anesthesia and AAA anesthesia in people with Parkinson Disease and Anesthesia, run by Shenzhen Second People's Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Compares the patients' scores of UPDRS-III before and six-month after receiving deep brain stimulation for Parkinson's disease under MAC or AAA anesthesia. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Parkinson Disease, Anesthesia
What is being tested?
MAC anesthesia and AAA anesthesia
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
1 Nov 2019to 31 May 2021
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 greater than 18 years old
  • Diagnosis of primary Parkinson's disease
  • Parkinson's disease-related symptoms remain difficult to control with appropriate anti-parkinsonian medications.

Who cannot join

  • Refusal to Participate in the research
  • Patients with severe comorbidities such as severe sleep apnea syndrome and metal disorder
  • Previous functional neurosurgery: DBS, thalamic incision, etc.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shenzhen Second People's Hospital

    Shenzhen, Guangdong, 518035

Other trials in China

About this study

Official title: UPDRS-III Comparisons of Deep Brain Stimulation for Parkinson's Disease Between Patients Receiving MAC and AAA Anesthesia: a Randomized Controlled Trial

Compares the patients' scores of UPDRS-III before and six-month after receiving deep brain stimulation for Parkinson's disease under MAC or AAA anesthesia.

Read the detailed description

Compares the patients' scores of UPDRS-III before and six-month after receiving deep brain stimulation for Parkinson's disease under MAC or AAA anesthesia. Besides, the research also compares the adverse events, LED, dosage of anesthetic drugs, wake-up time, surgical time, Hoehn\&Yahr, PQD-39, MMSE, MoCA, HAMA, HAMD and patients' satisfaction between the two groups mentioned above.

Being tested
MAC anesthesia, AAA anesthesia
Keywords
Parkinson's disease, UPDRS-III, Deep Brain Stimulation, MAC, AAA
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MAC anesthesiaProcedure or surgery

    Patients receives DBS under monitored anesthesia care.

  • AAA anesthesiaProcedure or surgery

    Patients receives DBS under asleep-awake-asleep anesthesia.

Study groups in NCT04361188
Study groupRoleWhat they receive
MAC anesthesia groupExperimentalParkinson's disease patients receiving deep brain stimulation under MAC anesthesia.
Receives: Procedure: MAC anesthesia
AAA anesthesia groupActive comparatorParkinson's disease patients receiving deep brain stimulation under AAA anesthesia.
Receives: Procedure: AAA anesthesia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Scores' change of Unified Parkinson's Rating Scale (part III/motor part)

    Compares the scores' change of Unified Parkinson's Rating Scale (part III/motor part) between the two groups.

    Measured: Before and six-month after DBS.

Secondary outcomes (12)

  1. Change of Levodopa Equivalent Dose

    Compares the change of Levodopa equivalent dose between the two groups.

    Measured: Before and six-month after DBS.

  2. Rates of Adverse Events

    Compares the rates of adverse events between the two groups.

    Measured: Intra-operative.

  3. Dosage of Anesthetic Drugs

    Compares the dosage of anesthetic between the two groups.

    Measured: Within surgery.

  4. Wake-up Time

    Compares the wake-up time between the two groups.

    Measured: Within surgery.

  5. Surgical Time

    Compares the surgical time between the two groups.

    Measured: Within surgery.

  6. Hoehn&Yahr

    Compares the Hoehn\&Yahr classification between the two groups' patients.

    Measured: Before surgery.

  7. Patients' Satisfaction(Visual Analogue Scale)

    Compares the scores of patients' satisfaction between the two groups' patients by Using a visual analogue scale. The minimum value is 0 and maximum value is 10. Higher value means greater satisfaction.

    Measured: 24 hours after surgery.

  8. Scores' change of 39-item Parkinson's Disease Questionnaire

    Compares the scores' change of 39-item Parkinson's Disease Questionnaire between the two groups.

    Measured: Before and six-month after DBS.

  9. Scores' change of Mini-mental State Examination

    Compares the scores' change of Mini-mental State Examination between the two groups.

    Measured: Before and six-month after DBS.

  10. Scores' change of Montreal Cognitive Assessment

    Compares the scores' change of Montreal Cognitive Assessment between the two groups.

    Measured: Before and six-month after DBS.

  11. Scores' change of Hamilton Anxiety Scale

    Compares the scores' change of Hamilton Anxiety Scale between the two groups.

    Measured: Before and six-month after DBS.

  12. Scores' change of Hamilton Depression Scale

    Compares the scores' change of Hamilton Depression Scale between the two groups.

    Measured: Before and six-month after DBS.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2020
  2. Study start1 Nov 2019
  3. Primary completion30 Sep 2020
  4. Study completion31 May 2021

Resources

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
Screening
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04361188
Sponsor's protocol ID
FS20191119007
Status last verified
Aug 2021
First submitted
21 Apr 2020
Last updated
17 Aug 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ho AL, Pendharkar AV, Brewster R, Martinez DL, Jaffe RA, Xu LW, Miller KJ, Halpern CH. Frameless Robot-Assisted Deep Brain Stimulation Surgery: An Initial Experience. Oper Neurosurg. 2019 Oct 1;17(4):424-431. doi: 10.1093/ons/opy395.

    PubMed 30629245

  • Kulikov A, Lubnin A. Anesthesia for awake craniotomy. Curr Opin Anaesthesiol. 2018 Oct;31(5):506-510. doi: 10.1097/ACO.0000000000000625.

    PubMed 29994938

  • Krauss P, Marahori NA, Oertel MF, Barth F, Stieglitz LH. Better Hemodynamics and Less Antihypertensive Medication: Comparison of Scalp Block and Local Infiltration Anesthesia for Skull-Pin Placement in Awake Deep Brain Stimulation Surgery. World Neurosurg. 2018 Dec;120:e991-e999. doi: 10.1016/j.wneu.2018.08.210. Epub 2018 Sep 7.

    PubMed 30196173

  • Kochanski RB, Sani S. Awake versus Asleep Deep Brain Stimulation Surgery: Technical Considerations and Critical Review of the Literature. Brain Sci. 2018 Jan 19;8(1):17. doi: 10.3390/brainsci8010017.

    PubMed 29351243

  • Ho AL, Ali R, Connolly ID, Henderson JM, Dhall R, Stein SC, Halpern CH. Awake versus asleep deep brain stimulation for Parkinson's disease: a critical comparison and meta-analysis. J Neurol Neurosurg Psychiatry. 2018 Jul;89(7):687-691. doi: 10.1136/jnnp-2016-314500. Epub 2017 Mar 1.

    PubMed 28250028

  • Chen T, Mirzadeh Z, Chapple KM, Lambert M, Shill HA, Moguel-Cobos G, Troster AI, Dhall R, Ponce FA. Clinical outcomes following awake and asleep deep brain stimulation for Parkinson disease. J Neurosurg. 2018 Mar 16;130(1):109-120. doi: 10.3171/2017.8.JNS17883. Epub 2018 Mar 16.

    PubMed 29547091

  • Chen T, Mirzadeh Z, Chapple KM, Lambert M, Evidente VGH, Moguel-Cobos G, Oravivattanakul S, Mahant P, Ponce FA. Intraoperative test stimulation versus stereotactic accuracy as a surgical end point: a comparison of essential tremor outcomes after ventral intermediate nucleus deep brain stimulation. J Neurosurg. 2018 Aug;129(2):290-298. doi: 10.3171/2017.3.JNS162487. Epub 2017 Oct 13.

    PubMed 29027853

  • Sheshadri V, Rowland NC, Mehta J, Englesakis M, Manninen P, Venkatraghavan L. Comparison of General and Local Anesthesia for Deep Brain Stimulator Insertion: A Systematic Review. Can J Neurol Sci. 2017 Nov;44(6):697-704. doi: 10.1017/cjn.2017.224. Epub 2017 Sep 18.

    PubMed 28920562

  • Grant R, Gruenbaum SE, Gerrard J. Anaesthesia for deep brain stimulation: a review. Curr Opin Anaesthesiol. 2015 Oct;28(5):505-10. doi: 10.1097/ACO.0000000000000230.

    PubMed 26308514

  • Erickson KM, Cole DJ. Anesthetic considerations for awake craniotomy for epilepsy and functional neurosurgery. Anesthesiol Clin. 2012 Jun;30(2):241-68. doi: 10.1016/j.anclin.2012.05.002. Epub 2012 Jul 3.

    PubMed 22901609

  • Bronstein JM, Tagliati M, Alterman RL, Lozano AM, Volkmann J, Stefani A, Horak FB, Okun MS, Foote KD, Krack P, Pahwa R, Henderson JM, Hariz MI, Bakay RA, Rezai A, Marks WJ Jr, Moro E, Vitek JL, Weaver FM, Gross RE, DeLong MR. Deep brain stimulation for Parkinson disease: an expert consensus and review of key issues. Arch Neurol. 2011 Feb;68(2):165. doi: 10.1001/archneurol.2010.260. Epub 2010 Oct 11.

    PubMed 20937936

Questions about this trial

What is this clinical trial studying?

A study testing MAC anesthesia and AAA anesthesia in people with Parkinson Disease and Anesthesia, run by Shenzhen Second People's Hospital at 1 site in China.

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 3 inclusion and 3 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: finished, as of the sponsor's last update on 17 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Scores' change of Unified Parkinson's Rating Scale (part III/motor part) (time frame: Before and six-month after DBS.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04361188, which also lists 11 linked publications.

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 Aug 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in