Action Tremor

Deep Brain Stimulation

Annual eReport to the South-Eastern Norway Health Authority

Oslo University Hospital

A Controlled Comparison of Two DBS Targets for Upper Extremity Action Tremor

Deep Brain Stimulation in Disabling Action Tremor: A Randomized, Double-blind Study Comparing the Ventral Intermediate Nucleus (VIM) of the Thalamus and the Posterior Subthalamic Area (PSA) / Zona Incerta (The TREMORSTIM Study)

The difference in the change from baseline to the end of each of the two 3-month randomized cross-over periods, in tremor of the contralateral upper limb(s), as evaluated by items 5,6,10-14 and 16-21 in the Fahn-Tolosa-Marin (FTM)-score with VIM- versus PSA-stimulation.

2) The difference in the change from baseline to the end of each of the two 3-month cross-over periods in the items scoring tremor of face/tongue/voice/trunk/lower limb(s), with VIM- versus PSA-stimulation.

Change from baseline to 1-yr with stimulation at the most optimal of 4 electrode contacts of each patient (selected after the second randomization period) of the total FTM-score, tremor of the upper limb(s) (same items as above) and of the items scoring tremor in the face, tongue, voice, trunk, lower limb(s).

Change from baseline to 1-yr of Quality of Life in Essential Tremor (QUEST) scale, and Visual Analogue Scale of Global Disease Burden as assessed by the patient.

Frequency of serious adverse events (surgical complications and stimulation related side-effects), including eventual deterioration on neuropsychological testing , registered during the first year of stimulation.

Inger Marie Skogseid

Consultant, MDPhD

South-Eastern Norway Regional Health Authority

Randomized allocation of half the patients to be stimulated the first 3 months in the VIM-nucleus of the thalamus (VIM) and then 3 months in the posterior subthalamic area (PSA), and for the other half the first 3 months in the PSA and the next 3 months in the VIM

The doctor who assesses the primary outcome measures at 3 and 6 months and the participant are both unaware of which of the two targets is stimulated in the two randomization periods.

Patients on deep brain stimulation for either obsessive-compulsive disorder or major depression, undergoing rechargeable neurostimulator implantation as intervention

Obsessive-compulsive Disorder

Depression

Rechargeable neurostimulators are implanted when the non-rechargeable neurostimulators are end-of-life.

Medtronic Restore Advanced 37713

Rechargeable Neurostimulators in Deep Brain Stimulation for Psychiatric Disorders

Feasibility Study Regarding the Implantation and Use of Rechargeable Neurostimulators in Deep Brain Stimulation for Psychiatric Disorders (Either Obsessive-compulsive Disorder or Major Depression)

Change in mean Yale‐Brown Obsessive Compulsive Scale (Y‐BOCS). Mean Y-BOCS during the first 2 years after intervention minus mean Y-BOCS during the last 2 years before intervention.

Change in Hamilton Depression Rating Scale (HAM‐D). Mean HAM-D during the first 2 years after intervention minus mean HAM-D during the last 2 years before intervention.

Change in Beck Depression Inventory (BDI). Mean BDI during the first 2 years after intervention minus mean BDI during the last 2 years before intervention.

Change in Global Assessment of Functioning (GAF). Mean GAF during the first 2 years after intervention minus mean GAF during the last 2 years before intervention.

Change in Stimulation amplitude as measured in volt. Mean stimulation amplitude during the first 2 years after intervention minus mean stimulation amplitude during the last 2 years before intervention.

Change in Stimulation frequency as measured in hertz Mean stimulation frequency during the first 2 years after intervention minus mean stimulation frequency during the last 2 years before intervention

Stimulation pulse width as measured in seconds. Mean stimulation pulse width during the first 2 years after intervention minus mean stimulation pulse width during the last 2 years before intervention.

Change in stimulation contact configuration as expressed in fraction of patients using a certain contact point as anode or cathode.
Fraction of patients using a certain contact point as cathode or anode during the first 2 years after intervention minus fraction of patients using a certain contact point as cathode or anode during the last 2 years before intervention.

Change in frequency of outpatient clinic contacts at the Psychiatry department. Frequency of outpatient clinic contacts at the Psychiatry department during the first 2 years after intervention minus frequency of outpatient clinic contacts at the Psychiatry department during the last 2 years before intervention.

Change in fraction of hospitalized days at the Psychiatry department. Fraction of hospitalized days at the Psychiatry department during the first 2 years after intervention minus fraction of hospitalized days at the Psychiatry department during the last 2 years before intervention.

Change in frequency of outpatient clinic contacts at the Neurosurgery department.
Frequency of outpatient clinic contacts at the Neurosurgery department during the first 2 years after intervention minus frequency of outpatient clinic contacts at the Neurosurgery department during the last 2 years before intervention.

Change in fraction of hospitalized days at the Neurosurgery department. Fraction of hospitalized days at the Neurosurgery department during the first 2 years after intervention minus fraction of hospitalized days at the Neurosurgery department during the last 2 years before intervention.

Change in frequency of neurosurgical procedures related to the DBS system. Frequency of neurosurgical procedures related to the DBS system after intervention minus frequency of neurosurgical procedures related to the DBS system before intervention.

Universitaire Ziekenhuizen Leuven

Medtronic

Functional Magnetic Resonance Imaging (fMRI) will be performed to determine the areas of BOLD signal modulation with DBS.

Parkinson Disease

Essential Tremor

Dystonia

Obsessive Compulsive Disorder

During the deep brain stimulation (DBS) surgery of the subthalamic nucleus within the thalamocortical basal ganglion, an additional lead extendor will be connected to the DBS electrode to allow externalization of the lead. Following confirmation of electrode location with MRI, a series of fMRI scans will be run. Total scanning time will be limited to 35 minutes.

Functional Magnetic Resonance Imaging (fMRI)

Mayo Clinic

Functional Magnetic Resonance Imaging (fMRI) During Deep Brain Stimulation (DBS) to Treat Parkinson's Disease

The UPDRS is a rating scale used to follow the longitudinal course of Parkinson's disease. The version of the scale used in this study has a total of 14 items; each of these item has a scale of 0-4, with 0 being no impairment, and 4 being severe impairment. All of the parts are combined to give a numeric score: 0 indicating no sign of disease, and 56, the highest score indicating severely incapacitated.

essential tremor/baş ağrısı

A Controlled Comparison of Two DBS Targets for Upper Extremity Action Tremor

Rechargeable Neurostimulators in Deep Brain Stimulation for Psychiatric Disorders

Functional Magnetic Resonance Imaging (fMRI) During Deep Brain Stimulation (DBS) to Treat Parkinson's Disease

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