NCT02154724

Brief Summary

Despite its therapeutic effectiveness in Parkinson's disease (PD) the current deep brain stimulation (DBS) strategy could achieve an even better clinical result by adapting to patient's condition. As intracerebral activity analyzed by recording local field potentials (LFPs) from DBS electrodes correlates to PD symptoms, a new stimulation approach would be an "intelligent" adaptive DBS system able to change stimulation settings automatically to the patient's needs using LFPs as control variable.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2014

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 3, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

June 3, 2014

Status Verified

May 1, 2014

Enrollment Period

1 year

First QC Date

May 19, 2014

Last Update Submit

May 30, 2014

Conditions

Advanced Parkinson's Disease

Outcome Measures

Primary Outcomes (2)

  • Percentage of improvement in unified parkindon's disease rating scale (UPDRS score) of aDSB compare to cDBS

    up to1 year

  • Number of participants with adverse events

    Counting the number of patient with adverse events (adimensional unit)

    up to 1 year

Study Arms (1)

aDBS

OTHER

The aDBS (adaptive Deep Brain Stimulation) device is applied both in aDBS and in DBS modality, for two hours in random order for two days. The aDBS can be programmed to deliver aDBS controlled by local fields potential or conventional DBS.

Device: aDBSDevice: DBS

Interventions

aDBSDEVICE

The aDBS is applied for 2 hours for two days with two different modalities (aDBS and DBS) in random order.

Also known as: adaptive deep brain stimulation, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
aDBS
DBSDEVICE

The aDBS s applied for two hous in DBS modality.

Also known as: Deep Brain Stimulation, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
aDBS

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Milan, Milano, 20122, Italy

RECRUITING

MeSH Terms

Interventions

Deep Brain Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsSurgical Procedures, Operative

Central Study Contacts

Alberto Priori, Prof.

CONTACT

alberto.priori@unimi.it

Study Design

Study Type
interventional
Phase
not applicable
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2014

First Posted

June 3, 2014

Study Start

September 1, 2013

Primary Completion

September 1, 2014

Study Completion

September 1, 2015

Last Updated

June 3, 2014

Record last verified: 2014-05

Locations

IT(1)