Clinical Trials Logo
  1. Home
  2. Essential Tremor
  3. NCT03875404
  4. Details
NCT03875404 Clinical Trial

Next-Generation Pre-Operative Targeting for Thalamic DBS in the Treatment of Tremor

Essential Tremor Clinical Trial

Official title:
Transform the Practice: Next-Generation Pre-Operative Targeting for Thalamic DBS in the Treatment of Tremor

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03875404
Other study ID # 18-010340
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 20, 2019
Est. completion date February 12, 2021

Study information
Verified date September 2021
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Researchers are investigating improved methods of targeting deep brain stimulators for treatment of essential tremor relying on brain connectivity measures derived from MRI.

Recruitment information / eligibility
Status Completed
Enrollment 9
Est. completion date February 12, 2021
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Diagnosis of refractory essential tremor scheduled for unilateral thalamic deep brain stimulator placement - Age = 18 years Exclusion Criteria: - Prior deep brain stimulator, stereotactic radiosurgery, or focused ultrasound procedure for treatment of tremor - Presence of concomitant movement disorder (e.g. Parkinson's disease, dystonia, etc.) - Known pre-existing structural brain abnormality (e.g, infarction, tumor, prior brain surgery, etc.) - Contraindication to 3 Tesla brain MRI (e.g. incompatible implanted device) - Pregnant

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Functional MRI
A special type of MRI measuring the metabolic changes that occur within the brain. It may be used to examine the brain's anatomy and determine which parts of the brain are handling critical functions. It helps identify important language and movement control areas in the brain.

Locations
Country Name City State
United States Mayo Clinic in Florida Jacksonville Florida

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in tremor rating score Fahn, Tolosa, Marin Tremor Rating Scale 1-9 Tremor (rate tremor)
0 = None
= Slight.
= Moderate amplitude.
= Marked amplitude
= Severe amplitude
0 = Normal
= Mildly abnormal.
= Moderately abnormal.
= Marked abnormal.
= Severely abnormal.		 One year
See also
  Status Clinical Trial Phase
Withdrawn NCT05381688 - VIM DBS Respiratory Modulation: N-of-1 Trial
Recruiting NCT05101161 - Neurofeedback Using Implanted Deep Brain Stimulation Electrodes N/A
Completed NCT02277106 - Evaluate SAGE-547 in Participants With Essential Tremor Phase 2
Recruiting NCT05769933 - Bridging Gaps in the Neuroimaging Puzzle: New Ways to Image Brain Anatomy and Function in Health and Disease Using Electroencephalography and 7 Tesla Magnetic Resonance Imaging
Terminated NCT02678429 - Atlas Predicted DBS Settings in Essential Tremor N/A
Terminated NCT02894567 - Evaluation of Directional Recording and Stimulation Using spiderSTN N/A
Completed NCT02523807 - Tremor Monitoring Device N/A
Active, not recruiting NCT02255929 - Gamma Knife Radiosurgery for Treatment of Essential Tremor N/A
Completed NCT01223144 - Decision-making and Emotion Recognition in Essential Tremor N/A
Completed NCT00906412 - Ventrointermediate Nucleus (VIM DBS) and Working Memory N/A
Recruiting NCT05214222 - Penpulimab Plus Chemotherapy With/Without Anlotinib for Patients With Advanced Esophageal Squamous Cell Carcinoma Phase 2
Completed NCT03051178 - Wearable Sensor for Responsive DBS for ET N/A
Recruiting NCT03795935 - Relief From Side Effects: Clinical Use of Electrodes With Direction N/A
Not yet recruiting NCT06036368 - Study to Evaluate Safety and Efficacy of Peroneal Transcutaneous NeuroModulation in Subjects With Parkinson's Disease and Essential Tremor N/A
Recruiting NCT05897775 - Coordinated Reset Deep Brain Stimulation for Essential Tremor Phase 1
Recruiting NCT05968976 - Multicentre RCT of Awake Versus Asleep Tractography Based DBS for ET N/A
Completed NCT06314139 - Tolerability and Efficacy of Continuous Theta-burst Stimulation for Essential Tremor: A Randomized Study. N/A
Recruiting NCT04501133 - Sensory-specific Peripheral Stimulation for Tremor Management N/A
Active, not recruiting NCT03560622 - Functional Neuroimaging Feedback for Focused Ultrasound Thalamotomy N/A
Completed NCT00368199 - Transcranial Duplex Scanning and Single Photon Emission Computer Tomography (SPECT) in Parkinsonian Syndromes N/A

External Links