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Using DBS to Probe Basal Ganglia Dysfunction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04080674
Recruitment Status : Not yet recruiting
First Posted : September 6, 2019
Last Update Posted : September 6, 2019
Sponsor:
Information provided by (Responsible Party):
University of Oxford

Brief Summary:
This study will probe the function of collections of neurons deep in the brain termed the basal ganglia It will investigate the role of the basal ganglia in how and why movement is disrupted in conditions like Parkinson's disease, Dystonia and Essential Tremor. Deep brain recording and stimulation will be used to probe the basal ganglia's contribution. Patients with relatively severe movement disorders may have electrodes implanted in the basal ganglia so that stimulation can be delivered chronically as a form of therapy. Studying these patients allows researchers (a) to record brain activity from these electrodes in the basal ganglia during symptoms related to abnormal motor control and (b) to stimulate the same electrodes while patients experience symptoms. Like this they can see what aspects of the activity of groups of nerve cells in the basal ganglia are associated with which symptoms and also establish that these aspects of activity help cause linked symptoms. This means studying patients just after electrode implantation, while the leads from the electrodes may still be available for hooking up to external recording and stimulating devices. Understanding how the activity of groups of nerve cells in the basal ganglia controls movement may help us develop improved treatments.

Condition or disease Intervention/treatment
Parkinson's Disease Tremor Dystonia Other: Feed-back controlled deep brain stimulation

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Studying the Role of the Basal Ganglia in Motor Symptoms Using Deep Brain Stimulation
Estimated Study Start Date : December 1, 2019
Estimated Primary Completion Date : November 30, 2023
Estimated Study Completion Date : November 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dystonia

Group/Cohort Intervention/treatment
Parkinson's disease
30 participants
Other: Feed-back controlled deep brain stimulation
Feed-back controlled deep brain stimulation

Essential Tremor
10 participants
Other: Feed-back controlled deep brain stimulation
Feed-back controlled deep brain stimulation

Dystonia
20 participants
Other: Feed-back controlled deep brain stimulation
Feed-back controlled deep brain stimulation




Primary Outcome Measures :
  1. Kinematic recordings [ Time Frame: During stimulation ]
    Change in kinematic data

  2. Electromyographic signals [ Time Frame: During stimulation ]
    Change in electromyographic data

  3. Disease relevant rating scale [ Time Frame: During stimulation ]
    Change in disease relevant rating scale



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing staged implantation of DBS electrodes
Criteria

Inclusion Criteria:

  • Participant is willing and able to give informed consent for participation in the study.
  • Male or Female, aged 18 to 80 years old.
  • Diagnosed with Parkinson's disease, Essential Tremor or Dystonia.
  • Undergoing two-stage surgery for deep brain stimulation as therapy for their movement disorder.

Exclusion Criteria:

  • Cognitive impairment (judged by the clinician on the care team or in the research team as a participant not having sufficient mental capacity to understand the study and its requirements). This includes anyone who, in the opinion of clinicians on the care team or clinicians in the research team, is unlikely to retain sufficient mental capacity for the duration of their involvement in the study.
  • Intracranial bleeding, confusion, cerebrospinal fluid leak or any other complication after the first stage of surgery.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04080674


Contacts
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Contact: Peter Brown, MD 01865 572 482 peter.brown@ndcn.ox.ac.uk

Locations
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United Kingdom
University of Oxford
Oxford, United Kingdom, OX3 9DU
Sponsors and Collaborators
University of Oxford
Investigators
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Principal Investigator: Peter Brown, MD University of Oxford
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Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT04080674    
Other Study ID Numbers: 271953
First Posted: September 6, 2019    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Dystonia
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Dyskinesias
Neurologic Manifestations