Effects of different concentrations of dexmedetomidine on basal ganglia neuronal activity (local field potentials) in Parkinson's disease.

Phase 1

• Conditions: Parkinson's disease; MedDRA version: 19.0Level: LLTClassification code 10013113Term: Disease Parkinson'sSystem Organ Class: 100000004852; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2016-002680-34-ES
• Lead Sponsor: Clínica Universidad de Navarra/Universidad de Navarra

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-05
• Last Update Posted: 7 January 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

1. Patients undergoing placement of DBS for PD in two phases.
2. The patient must be of legal age (> 17 years old).
3. The patient or his representative has consented to participate in the study.
4. The patient should, in the investigator's opinion be able to cooperate during the procedure.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 4
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8

Exclusion Criteria

1. Known liver disease.
2. Pregnant or nursing women.
3. History of hypersensitivity to dexmedetomidine.
4. Heart block (2nd or 3rd degree), without pacemaker.
5. Symptomatic hypotension.
6. Severe stroke or other neurological deficits that may impair adequate cooperation or observation of the study endpoints

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified