Pilot Study Evaluating Safety of Unilateral Gamma Knife Subthalamotomy for

Status Terminated

Clinical Trial Summary

This is a pilot study to evaluate the safety and efficacy of unilateral gamma knife subthalamotomy for Parkinson's disease in patients deemed poor candidates for deep brain stimulation.

Clinical Trial Description

The goal of the study is to enroll 20 subjects who could benefit from unilateral subthalamotomy due to the presence of unilateral rigidity, tremor, bradykinesia and/or dyskinesias (as opposed to axial symptoms such as walking) but who are suboptimal candidates for deep brain stimulation (DBS) because of advanced age (>74), medical comorbidities precluding surgery, or patient aversion to DBS, and who show more than 30% improvement in Unified Parkinson's Disease Rating Scale (UPDRS) score in the ON versus OFF medication state.

Secondary objectives will focus on the efficacy of Gamma Knife (GK) subthalamotomy for Parkinson's disease (PD), as determined by changes in the patient's clinical status and any improvement following the treatment. A full neurologic exam as well as a screen for depression will be administered at every postoperative visit. The patient's neurologic function will be assessed with a full neurological examination and objectively quantified using the UPDRS focusing on the contralateral side, as well as overall UPDRS.

The clinician will complete a Clinical Global Impression (CGI) and Mini-Mental State Examination (MMSE) at each visit to record overall impression of the patient's disease progression and severity, and to evaluate cognitive function. Pre- and post-treatment assessment of the Levodopa Equivalent Daily Dose (LEDD) (quantification of medication regimen in levodopa equivalents) will be obtained and recorded to evaluated the efficacy of gamma knife subthalamotomy (GKS) as a treatment for Parkinson's disease (PD). A Parkinson's Disease Questionnaire-39 (PDQ-39) to determine the patient's independence and quality of life will be filled out at each visit. Finally, the patient will complete a Beck Depression Inventory at each clinic visit to monitor for development or progression of depressive symptoms. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02249559
Study type	Observational
Source	New York University School of Medicine
Contact
Status	Terminated
Phase	N/A
Start date	July 2014
Completion date	September 2017

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05565443` - MR-guided Focused Ultrasound Plus GCase	N/A
Completed	`NCT01941732` - Motor Response to Sildenafil in PD	Phase 4
Active, not recruiting	`NCT04777331` - A Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants With Early Parkinson's Disease	Phase 2
Completed	`NCT02452125` - The Effects of Nicotine Chewing Gum in Parkinson's Disease	N/A
Completed	`NCT02569021` - Battery-preserving Stimulation Patterns for Deep Brain Stimulation	N/A
Recruiting	`NCT05568199` - Udall Project 1 Aim 4
Completed	`NCT02676804` - Exercise Dosing Trial for Individuals With Parkinson's Disease	N/A
Completed	`NCT02092181` - A Pilot Study of Mirabegron and Behavioral Modification Including Pelvic Floor Exercise for Overactive Bladder in Parkinson's Disease (MAESTRO)	Phase 4
Completed	`NCT01163344` - Dance Exercise as Novel Complementary Therapy for Parkinson's Disease	N/A
Recruiting	`NCT05539196` - A Post-Approval Registry for Exablate 4000 Type 1.0 and Type 1.1 for Unilateral Pallidotomy for the Treatment of Advanced, Idiopathic Parkinson's Disease With Medication-refractory Moderate to Severe Motor Complications
Completed	`NCT02318927` - A Responsive Closed-Loop Approach to Treat Freezing of Gait in Parkinson's Disease	N/A
Active, not recruiting	`NCT01417598` - BETA Study: Improving Balance Function in Elderly by Progressive and Specific Training and Physical Activity	N/A
Withdrawn	`NCT01256905` - Attention Modulation for Treatment of Parkinson's Disease and Dementia With Lewy Bodies	N/A
Completed	`NCT01789385` - Anesthesia for Deep Brain Stimulation	Phase 4
Completed	`NCT01360229` - Acupuncture for Fatigue in Parkinson's Disease	N/A
Recruiting	`NCT02126475` - Temporal Expectations in Parkinson's Disease	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Pilot Study Evaluating Safety of Unilateral Gamma Knife Subthalamotomy for Parkinson's Disease — GKSTN

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms