E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Parkinson's disease |
Enfermedad de Parkinson |
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E.1.1.1 | Medical condition in easily understood language |
Parkinson's disease |
Enfermedad de Parkinson |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10013113 |
E.1.2 | Term | Disease Parkinson's |
E.1.2 | System Organ Class | 100000004852 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To study and quantify the possible effect of different doses of dexmedetomidine (0.2-0.6 µg/kg/h) on the local field potentials (deep brain activity) in patients with Parkinson´s disease undergoing deep brain stimulation implantion. |
Conocer la dosis máxima de dexmedetomidina, entre 0,2 – 0,6 µg/kg/h, que se puede administrar en pacientes sometidos a colocación de ECP por EP sin interferir en la actividad cerebral profunda (potenciales de campo local) |
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E.2.2 | Secondary objectives of the trial |
1- To make an observational comparative analysis of possible changes in tremor of the patients between control and different concentrations of dexmedetomidine. 2- To study the relationship between the effect of dexmedetomidine on the LFPs of the basal ganglia and frontal cortical activity (bispectral index©).
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1- Profundizar en el efecto de la dexmedetomidina en el temblor de los pacientes con EP. 2- Estudiar la relación del efecto que la dexmedetomidina ejerce en los PCL de los ganglios basales y la actividad cortical frontal (medida median BIS bilateral). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
1. Pacientes sometidos a colocación de ECP por enfermedad de Parkinson (NST o GPi) en dos tiempos. 2. El paciente deberá ser mayor de edad. 3. El paciente, o su representante, ha otorgado su consentimiento para participar en el estudio. 4. El paciente debe, en opinión del investigador, ser capaz de cumplir con todos los requerimientos del ensayo clínico. |
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E.4 | Principal 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 |
1. Insuficiencia hepática grave (enfermedad hepática conocida). 2. Mujeres embarazadas o en período de lactancia. La detección de embarazo se realiza de manera rutinaria previamente al procedimiento de colocación del ECP, por lo que no es necesario volver a realizar la prueba de embarazo. 3. Antecedentes de hipersensibilidad a dexmedetomidina. 4. Bloqueo cardíaco en 2º o 3º grado sin marcapasos. 5. Hipotensión sintomática. 6. Paciente con enfermedad cerebrovascular grave. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Local field potentials (deep brain activity) recording with the deep brain stimulator under different doses of dexmedetomidine. |
"Registro con dexmedetomidina” de los PCL (actividad cerebral profunda) con diferentes dosis de dexmedetomidina a través del ECP. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Before the second surgery phase (implanting of programmable pulse generator and connection to the deep brain stimulator), in “off” medication and without any residual effect of anesthetic drugs, the patient will be transfer to the post-anesthetic care unit for the administration of dexmedetomidine and recording the local field potentials. |
Antes de empezar el segundo tiempo de la cirugía (colocación del generador de pulsos y conexión al sistema de estimulación cerebral profunda), sin haber recibido su medicación para el tratamiento del Párkinson ni otro tipo de medicación anestésica, el paciente será trasladado a la sala de recuperación anestésica para la administración de la dexmedetomidina y el registro de los potenciales de campo local. |
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E.5.2 | Secondary end point(s) |
• Demographic variables (sex, age, weight, BMI). • Patient diagnosis and duration of PD. • “Basal tremor” score on the UPDRS-III in state "off" before the surgery. • Stimulation target (STN or Gpi). • Type of intervention. • “Control recording” of LFPs (deep brain activity) through the DBS. • “Dexmedetomidine recording” of local field potentials (deep brain activity) at different concentrations of dexmedetomidine through the deep brain stimulation electrode. • “Control tremor” and “dexmedetomidine tremor” score at different concentration. • Frontal cortical activity (bilateral bispectral index). • Adverse events by the administration of dexmedetomidine |
• Variables demográficas (sexo, edad, peso, IMC). • Diagnóstico del paciente y tiempo de evolución de la enfermedad. • Puntuación basal del temblor en la escala UPDRS-III en “off” previo a la primera intervención (“temblor basal”) • Diana de estimulación (NST o GPi). • Tipo de intervención (uni o bilateral). • “Registro de control” de los PCL (actividad cerebral profunda) a través del ECP. • “Registro con dexmedetomidina” de los PCL (actividad cerebral profunda) con diferentes dosis de dexmedetomidina a través del ECP. • “Temblor control” y “temblor con dexmedetomidina” a diferentes concentraciones. • Actividad del electroencefalograma cortical frontal a través del análisis procesado del BIS bilateral. • Posible aparición de acontecimientos adversos por la administración del fármaco en estudio.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
At different moments during the study |
A lo largo del estudio |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
En el mismo paciente |
In the same patient |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Estado basal |
Basal condition |
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E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 18 |
E.8.9.1 | In the Member State concerned days | |