Responsive Deep Brain Stimulator for Essential Tremor
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 12/27/2018 |
| Start Date: | February 1, 2017 |
| End Date: | November 2021 |
| Contact: | Aysegul Gunduz, Ph.D |
| Email: | agunduz@ufl.edu |
| Phone: | 3522736877 |
Closing the Loop on Tremor: A Responsive Deep Brain Stimulator for the Treatment of Essential Tremor
Essential tremor is an incurable, degenerative brain disorder that results in increasingly
debilitating tremor, and afflicts an estimated 7 million people in the US. In one study, 25%
of essential tremor patients were forced to change jobs or take early retirement because of
tremor. Essential tremor is directly linked to progressive functional impairment, social
embarrassment, and even depression. The tremor associated with essential tremor is typically
slow, involves the hands (and sometimes the head and voice), worsens with intentional
movements, and is insidiously progressive over many years. Deep brain stimulation has emerged
as a highly effective treatment for intractable, debilitating essential tremor. However,
since the intention tremor of essential tremor is typically intermittent, and commonly absent
at rest, the currently available continuous deep brain stimulation may be delivering
unnecessary current to the brain that increases undesirable side effects such as slurred
speech and walking difficulty, and hastens the depletion of device batteries, necessitating
more frequent surgical procedures to replace spent pulse generators. The overall objective of
this early feasibility study is to provide preliminary data on the safety and efficacy of
"closed-loop" deep brain stimulation for intention tremor using novel deep brain stimulation
devices capable of continuously sensing brain activity and delivering therapeutic stimulation
only when necessary to suppress tremor.
debilitating tremor, and afflicts an estimated 7 million people in the US. In one study, 25%
of essential tremor patients were forced to change jobs or take early retirement because of
tremor. Essential tremor is directly linked to progressive functional impairment, social
embarrassment, and even depression. The tremor associated with essential tremor is typically
slow, involves the hands (and sometimes the head and voice), worsens with intentional
movements, and is insidiously progressive over many years. Deep brain stimulation has emerged
as a highly effective treatment for intractable, debilitating essential tremor. However,
since the intention tremor of essential tremor is typically intermittent, and commonly absent
at rest, the currently available continuous deep brain stimulation may be delivering
unnecessary current to the brain that increases undesirable side effects such as slurred
speech and walking difficulty, and hastens the depletion of device batteries, necessitating
more frequent surgical procedures to replace spent pulse generators. The overall objective of
this early feasibility study is to provide preliminary data on the safety and efficacy of
"closed-loop" deep brain stimulation for intention tremor using novel deep brain stimulation
devices capable of continuously sensing brain activity and delivering therapeutic stimulation
only when necessary to suppress tremor.
The purpose of this study is to investigate brain signals related to intention tremor in
essential tremor in order to deliver deep brain stimulation only when the patient is showing
symptoms. By delivering stimulation only when needed, the investigators hypothesize that the
treatment will be more effective, will cause fewer adverse side effects and will increase
battery time of the device (reducing the number of battery replacement surgeries).
Participation in this study will require extensive pre-surgical screening to determine
eligibility for deep brain stimulation surgery, a deep brain stimulation surgical procedure,
and regular follow-ups. Subjects will be seen monthly post surgery for 6 months. After 6
months, data will be assessed and closed-loop deep brain stimulation may be offered as a
stimulation setting. If so, the stimulator settings will be changed from chronic to
responsive. If not, the subject will continue to receive chronic deep brain stimulation
stimulation. Subsequent visits will be scheduled every 6 months until a total of 24 months of
study participation (also at month 9).
At the end of the initial 24-month study period, subjects will have the choice of 1)
continuing active stimulation at the current setting, 2) continuing stimulation but searching
for a new setting, 3) discontinuing stimulation (turning the device off), 4) having the
device removed. If the subject continues to receive active stimulation, they will be followed
by the investigators and seen at yearly intervals.
essential tremor in order to deliver deep brain stimulation only when the patient is showing
symptoms. By delivering stimulation only when needed, the investigators hypothesize that the
treatment will be more effective, will cause fewer adverse side effects and will increase
battery time of the device (reducing the number of battery replacement surgeries).
Participation in this study will require extensive pre-surgical screening to determine
eligibility for deep brain stimulation surgery, a deep brain stimulation surgical procedure,
and regular follow-ups. Subjects will be seen monthly post surgery for 6 months. After 6
months, data will be assessed and closed-loop deep brain stimulation may be offered as a
stimulation setting. If so, the stimulator settings will be changed from chronic to
responsive. If not, the subject will continue to receive chronic deep brain stimulation
stimulation. Subsequent visits will be scheduled every 6 months until a total of 24 months of
study participation (also at month 9).
At the end of the initial 24-month study period, subjects will have the choice of 1)
continuing active stimulation at the current setting, 2) continuing stimulation but searching
for a new setting, 3) discontinuing stimulation (turning the device off), 4) having the
device removed. If the subject continues to receive active stimulation, they will be followed
by the investigators and seen at yearly intervals.
Inclusion Criteria:
1. You provide informed consent.
2. You are over 21 years of age.
3. You are diagnosed with a postural-intention (essential) tremor for at least 3 years
and meet strict diagnostic criteria and have been seen and examined by a movement
disorders fellowship trained neurologist.
4. You have had a significant disabling medical-refractory upper extremity tremor with no
evidence of supraspinal central nervous system disease or injury (tremor not
adequately controlled by medications for at least three (3) months before implant).
5. You have had a postural or kinetic tremor severity score of at least 2 out of 4 in the
extremity intended for treatment on the Fahn-Tolosa-Marin Clinical Rating Scale for
Tremor (CRST).
6. You have had a CRST score of 2 or above in any one of the items 16-23 from the
Disability subsection of the CRST: speaking, feeding other than liquids, bringing
liquids to mouth, hygiene, dressing, writing, working and social activities.
7. Your tremor is refractory adequate trials of at least two medications, one of which
should be either propranolol or primidone. An adequate medication trial is defined as
a therapeutic dose of each medication or the development of side effects as the
medication dose is titrated.
8. You are available for appropriate follow-up times for the length of the study.
Exclusion Criteria:
1. Any previous neurosurgical intervention including deep brain stimulation or ablative
brain lesions.
2. Medication related movement disorders.
3. Any suspicion of Parkinsonian tremor, including presence of Parkinsonian features such
as bradykinesia, rigidity, or postural instability.
4. Any behaviors consistent with ethanol or substance abuse as defined by the criteria
outlined in DSM-V.
5. Severe medical co-morbidity including cardiovascular disorder, lung disorder, kidney
disease, continuous neurological disease, hematological disease, or frailty that
impact tolerability of the surgery as judged by the screening physicians.
6. Abnormal brain MRI including hydrocephalus, stroke, structural lesions, demyelinating
lesions, or infectious lesions. Also excluded will be subjects with severe atrophy.
7. Any uncontrolled symptoms or signs of increased intracranial pressure (e.g., headache,
nausea, vomiting, lethargy, papilledema).
8. A history of seizures within the past year.
9. A dementia rating scale score (DRS) <130 signifying significant cognitive dysfunction
and a potential for inability to cooperate with tasks involved in the study.
10. Any attempt or intent of suicide in the last six months.
11. Presence or history of psychosis.
12. Significant or active mood disorders including depression. For the purpose of this
study, we consider a significant mood disorder to include any subject who has:
1. Scores ≥ 20 on the Patient Health Questionnaire - 9 (PHQ-9).
2. Currently under the care of a psychiatrist
3. Currently participating in cognitive-behavioral therapy
4. Been hospitalized for the treatment of a psychiatric illness within 12 months
5. Ever received transcranial magnetic stimulation
6. Ever received electroconvulsive therapy
n. In addition, patients who are pregnant or plan to become pregnant will be excluded from
this study.
We found this trial at
1
site
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
Click here to add this to my saved trials
