Comparison of Outcomes in Asleep and Awake DBS With a Directional Electrode

Parkinson Disease Clinical Trial

Official title:

Comparison of Outcomes in Asleep and Awake DBS With a Directional Electrode

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04287465
• Other study ID #: HospitalHDU
• Status: Active, not recruiting
• Start date: August 1, 2018
• Est. completion date: December 31, 2025

Study information

• Verified date: September 2023
• Source: Hospital District of Helsinki and Uusimaa
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To compare the clinical outcome of patients with Parkinson's disease (PD) treated with directional deep brain (dDBS) stimulation undergoing subthalamic deep brain stimulation operation (STN-DBS) under general anesthesia versus local anesthesia.

Description:

To compare the clinical outcome of patients with Parkinson's disease (PD) treated with directional deep brain (dDBS) stimulation undergoing subthalamic deep brain stimulation operation (STN-DBS) under general anesthesia versus local anesthesia.

In awake group, 10 patients with Parkinson's disease were treated with St Jude Medical/Abbott Infinity DBS system, and the electrode implantation and testing were performed while the patients were awake. In asleep group, 14 patients with Parkinson's disease were treated with St Jude Medical/Abbott Infinity DBS system, and the electrode implantation were performed while the patients were under general anesthesia. The clinical outcome of the DBS treatment, possible adverse effects and the electrode placement will be compared within these two groups.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 31, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 80 Years

Eligibility

Inclusion Criteria:

Advanced Parkinson's disease

• The clinical decision of DBS treatment

• The clinical inclusion criteria of DBS treatment:

• drug-resistant tremor

• severe daily motor fluctuations or dyskinesia in despite of the optimal oral medication

• an improvement of UPDRS III scores over 30 % in levodopa challenge test.

Exclusion Criteria:

• The general exclusion criteria for DBS treatment:

• a major depression

• on-going psychosis

• a significant brain atrophy observed in a brain MRI

• a suspicion of atypical parkinsonism

• marked cognitive decline.

Related Conditions & MeSH terms

• Deep Brain Stimulation
• Parkinson Disease

Locations

Country	Name	City	State
Finland	HUH Meilahti Hospital, department of neurology	Helsinki

Sponsors (2)

Lead Sponsor	Collaborator
Hospital District of Helsinki and Uusimaa	University of Turku

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change of UPDRS III score	The UPDRS III score (0-60 points) at 6-months' follow-up compared to preoperative UPDRS III score	6 months
Secondary	The change of levodopa equivalent dose, LED	The change of levodopa equivalent dose (LED 0 - 2000 mg) at 6-months' follow-up compared to preoperative LED	6 months
Secondary	Electrode trajectory	The comparison of the actual trajectory of the DBS electrode and the anticipated trajectory of the DBS electrode in both patient groups	6 months