Study Summary
This trial will test the effects of electrical stimulation on a specific nerve pathway in the brain in order to improve symptoms of Parkinson's disease.
Eligible Conditions
- Essential Tremor
Treatment Effectiveness
Effectiveness Progress
Study Objectives
7 Primary · 2 Secondary · Reporting Duration: During DBS placement surgery during active DBS
Month 24
Structural connectivity as indicated by axial diffusivity as measured by diffusion tensor imaging (DTI) MRI
Structural connectivity as indicated by fractional anisotropy (FA) as measured by diffusion tensor imaging (DTI) MRI
Structural connectivity as indicated by mean diffusivity as measured by diffusion tensor imaging (DTI) MRI
Structural connectivity as indicated by radial diffusivity as measured by diffusion tensor imaging (DTI) MRI
Hour 72
Ataxia as assessed by score on the Scale for the Assessment and Rating of Ataxia (SARA)
Functional connectivity as indicated by blood oxygen level dependent (BOLD) signal as measured by resting state functional MRI (rsfMRI)
Tremor
During DBS placement surgery during active DBS
Spectral power recorded during intraoperative electrocorticography (ECoG)
Tremor
Trial Safety
Safety Progress
Side Effects for
Deep Brain Stimulation
23%Fall
15%Depression
8%Restless legs syndrome
8%Apathy
8%Hand fracture
5%Urinary tract infection
5%Speech disorder
5%Influenza
5%Head injury
5%Dystonia
5%Tremor
5%Gait disturbance
5%Skeletal injury
5%Paraesthesia
5%Back pain
5%Dyspepsia
3%Rapid eye movements sleep abnormal
3%Ingrowing nail
3%Hallucination, auditory
3%Impulse-control disorder
3%Insomnia
3%Panic attack
3%Depressed mood
3%Confusional state
3%Implant site infection
3%Localised infection
3%Staphylococcal infection
3%Device migration
3%Joint sprain
3%Skin laceration
3%Parkinson's disease
3%Syncope
3%Fibula fracture
3%Rib fracture
3%Memory impairment
3%Movement disorder
3%Nerve root lesion
3%Sciatica
3%Bronchitis
3%Ear infection
3%Incision site infection
3%Bursitis
3%Intervertebral disc protrusion
3%Neck pain
3%Pain in extremity
3%Spinal osteoarthritis
3%Adverse drug reaction
3%Axillary pain
3%Drug withdrawal syndrome
3%Implant site haematoma
3%Oedema peripheral
3%Productive cough
3%Diabetes mellitus
3%Fluid retention
3%Folate deficiency
3%Macular degeneration
3%Laboratory test abnormal
3%Pericardial effusion
3%Seborrhoeic keratosis
3%Urinary incontinence
3%Respiratory depression
3%Anxiety
3%Cyst
3%Hypertension
3%Hypotension
3%Pneumonia
3%Cystitis
3%Akinesia
3%Helicobacter gastritis
3%Alcohol poisoning
3%Thermal burn
3%Cerebral microangiopathy
3%Hypoaesthesia
3%Contusion
3%Dysarthria
3%Anger
3%Postoperative wound infection
3%Arthralgia
3%Cough
3%Pleural effusion
3%Monarthritis
3%Osteoarthritis
3%Diplopia
3%Pyrexia
3%Weight increased
3%Thrombophlebitis
Trial Design
1 Treatment Group
Deep Brain Stimulation(DBS)
1 of 1
Experimental Treatment
72 Total Participants · 1 Treatment Group
Primary Treatment: Deep Brain Stimulation · No Placebo Group · N/A
Deep Brain Stimulation(DBS)
Device
Experimental Group · 1 Intervention: Deep Brain Stimulation · Intervention Types: DeviceTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Deep Brain Stimulation
2011
Completed Phase 2
~700
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: during dbs placement surgery during active dbs
Who is running the clinical trial?
The University of Texas Health Science Center, HoustonLead Sponsor
812 Previous Clinical Trials
256,187 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,444 Previous Clinical Trials
24,578,371 Total Patients Enrolled
1 Trials studying Essential Tremor
30 Patients Enrolled for Essential Tremor
Albert J Fenoy, MD3.554 ReviewsPrincipal Investigator - The University of Texas Health Science Center, Houston
The University of Texas Health Science Center, Houston
1 Previous Clinical Trials
50 Total Patients Enrolled
2Patient Review
I was extremely disappointed with my appointment with Dr. Fenoy. He spent the vast majority of the time talking about his own issues with insurance, rather than listening to my concerns. He also seemed completely uninterested in helping me find a way to get the treatment I needed. Thankfully, I was able to find another doctor who was able to help me.
Eligibility Criteria
Age 18 - 85 · All Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have tremors that are refractory to multiple medication regimens and/or where the medications cause intolerable side effects.
You have a tremor that is severely impacting your quality of life.
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