Deep Brain Stimulation for Autonomic and Gait Symptoms in Multiple System Atrophy (STAG-MSA)
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|ClinicalTrials.gov Identifier: NCT03593512|
Recruitment Status : Recruiting
First Posted : July 20, 2018
Last Update Posted : October 15, 2018
Patients referred to neurosurgery routinely and safely undergo deep brain stimulation (DBS) for treatment of symptoms related to neurodegenerative conditions, most commonly Parkinson's disease.
In the investigators experience, and published evidence shows, that stimulation has effects on the autonomic nervous system. In patients undergoing therapeutic DBS for a particular subtype of Parkinsonism, Multiple System Atrophy, the further effects on autonomic parameters such as blood pressure and bladder symptoms as well as the originally intended indications (gait and movement disorder) will be investigated. The mechanisms of any effects will also be studied by using a number of techniques such as magnetoencephalography (MEG) and Muscle Sympathetic Nerve Activity (MSNA) recording.
Key goals are to:
- Demonstrate that stimulation of the peduculopontine nucleus (PPN) improves autonomic function and has an attendant improvement on patients' quality of life
- Investigate the role of the PPN and how it interacts with other brain areas.
This translational strategy will lead to a larger efficacy study of DBS for MSA as well as revolutionizing neural-based treatments in other autonomic disorders such as orthostatic hypotension and pure autonomic failure.
|Condition or disease||Intervention/treatment||Phase|
|Multiple System Atrophy Autonomic Failure Postural Hypotension Bladder, Neurogenic Gait Disorders, Neurologic||Procedure: Deep brain stimulation||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Evaluation of symptomatology before and after implantation of DBS electrodes; followed by cross-over of "on" and "off" stimulation|
|Masking:||None (Open Label)|
|Official Title:||Deep Brain Stimulation for Autonomic and Gait Symptoms in Multiple System Atrophy|
|Actual Study Start Date :||September 9, 2018|
|Estimated Primary Completion Date :||February 2021|
|Estimated Study Completion Date :||August 2021|
Experimental: PPN DBS
All patients will undergo bilateral PPN DBS
Procedure: Deep brain stimulation
Bilateral deep brain stimulation of the pedunculopontine nucleus
- EuroQol 5 Dimension (5 level) score before and after deep brain stimulation [ Time Frame: Through study completion, but on average, over an 8 month period for each patient ]Measurement of quality of life before and after surgery. Results will be given as description of health states - it is not quantitative.
- Fluency of gait as measured by accelerometry before and after deep brain stimulation [ Time Frame: Through study completion, but on average, over an 8 month period for each patient ]Measurement of gait parameters before and after surgery
- Modified composite autonomic symptom scale before and after deep brains stimulation [ Time Frame: Through study completion, but on average, over an 8 month period for each patient ]Measurement of autonomic symptomatology before and after surgery - Score from 0-100
- Change in postural blood pressure change before and after PPN DBS [ Time Frame: Through study completion, but on average, over an 8 month period for each patient ]Measurement of effect on postural blood pressure change before and after surgery
- Number of Participants With Treatment-Related Adverse Events as Assessed by using approved UK reporting procedure [ Time Frame: Through study completion, 2 years ]To assess the safety of PPN DBS on MSA patients by recording adverse events
- Muscle sympathetic nerve activity before and after deep brain stimulation [ Time Frame: Through study completion, but on average, over an 8 month period for each patient ]To determine whether or not PPN suppression or excitation alters sympathetic outflow by measuring the activity in autonomic nerves in the leg
- Cortical magentoencephalography profile with deep brain stimulation on and off [ Time Frame: 3-6 months after surgery ]Identification in change of cortical magetic activity with DBS on and off
- Physical anatomical white matter connections between the pedunculopontine nucleus and the rest of the central nervous system [ Time Frame: Before surgery and 3-6 months after surgery ]To identify the physical anatomical relations of the stimulated region of brain by looking at high resolution structural imaging studies
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): NCT03593512
|Contact: Sean C Martin, MRCS(Eng)||firstname.lastname@example.org|
|Contact: Alexander L Green, FRCS(SN)||email@example.com|
|John Radcliffe Hospital||Recruiting|
|Oxford, Oxfordshire, United Kingdom, OX3 9DU|
|Contact: Sean C Martin firstname.lastname@example.org|
|Contact: Alexander L Green email@example.com|
|Principal Investigator:||Alex L Green, FRCS(SN)||University of Oxford|