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Tremor clinical trials

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NCT ID: NCT05795218 Not yet recruiting - Essential Tremor Clinical Trials

directSTIMâ„¢ Deep Brain Stimulation System Post-Market Clinical Follow-up Study on Essential Tremor

Start date: October 2023
Phase:
Study type: Observational

This is a prospective, multi-center, single arm post-market clinical follow-up study. The present study investigates a product authorized on the European market that will be used per its intended use, and all procedures involved follow the standard of care. This is an observational study to provide clinical evidence in support of DBS effectiveness in the treatment of ET when delivered by the directSTIM DBS system. Twenty-one patients will be enrolled in this study. Subjects selected to participate in the study will be ET patients referred to uni- or bilateral DBS implant who meet the inclusion criteria and none of the exclusion criteria. Primary effectiveness variables will be measured at baseline for the identification of the worst limb (most affected by the disease), then 3 months post-surgery. Safety events will be collected between implant and 3-month visit, to evaluate potential confounding factors. After completing the 3-month visit, subjects will exit the study, and continue to be followed by their physician per usual care. Study will be conducted at minimum 3 centers in Europe.

NCT ID: NCT05456451 Not yet recruiting - Parkinson Disease Clinical Trials

Effectiveness of Noninvasive Vagus Stimulation for Upper Extremity in Parkinson's Disease

Start date: July 25, 2022
Phase: N/A
Study type: Interventional

Vagus nerve stimulation in the treatment of PD is a non-pharmacological intervention with the potential to improve gait, cognition, fatigue, and autonomic functions, but more evidence is needed for VSS in the treatment of PD. The potential mechanisms of VSS in the improvement seen in PD are explained by increased cholinergic transmission, decreased neuroinflammation, and enhanced NE release. In this study, it was aimed to investigate the effects of non-invasive vagus nerve stimulation to be applied to patients with Parkinson's disease on tremor and vagus nerve activity in patients. The tremor and autonomic activations of the participants will be evaluated at pre and post treatment.

NCT ID: NCT05350709 Not yet recruiting - Parkinson Disease Clinical Trials

Action Observation Therapy and Mirror Therapy in Parkinson's Disease

Start date: April 25, 2022
Phase: N/A
Study type: Interventional

Small muscles of the hand are affected due to involuntary movements and slowing of voluntary movements seen in Parkinson's disease. There is a loss of fine dexterity and coordination in the hand. It becomes difficult for patients to grasp and release of the objects. They become unable to perform daily activities such as buttoning up, holding keys, brushing teeth, holding forks, spoons and glasses, and writing. Therefore, a certain part of the rehabilitation program should be devoted to upper extremity rehabilitation. The aim of this study was to compare the effects of action observation therapy and mirror therapy, which have been used in the literature for many years, on upper extremity functions and quality of life in individuals with Parkinson's disease.

NCT ID: NCT05170022 Not yet recruiting - Essential Tremor Clinical Trials

Clinical Profile in Patients With Essential Tremors

Start date: March 1, 2022
Phase:
Study type: Observational

Essential tremors are no longer a single motor disorder but disorder of movement associated with non-motor symptoms and the aim of this study is to explore the clinical profile of patients with essential tremors including motor and non-motor features and their relationship. and to identify clinical predictors of these features.

NCT ID: NCT04810325 Not yet recruiting - Parkinson Disease Clinical Trials

Brain Sensing in Neurological and Psychiatric Disorders

Start date: July 1, 2021
Phase:
Study type: Observational

High-frequency deep brain stimulation (DBS) is an effective treatment strategy for a variety of movement disorders including Parkinson's disease, dystonia and tremor1-5, as well as for other neurological and psychiatric disorders e.g. obsessive compulsive disorder, depression, cluster headache, Tourette syndrome, epilepsy and eating disorders6-11. It is currently applied in a continuous fashion, using parameters set by the treating clinician. This approach is non-physiological, as it applies a constant, unchanging therapy to a dysfunctional neuronal system that would normally fluctuate markedly on a moment-by moment basis, depending on external stressors, cognitive load, physical activity and the timing of medication administration. Fluctuations in physical symptoms reflect fluctuations in brain activity. Tracking and responding in real-time to these would allow personalised approaches to DBS through stimulating at appropriate intensities and only when necessary, thereby improving therapeutic efficacy, preserving battery life and potentially limiting side-effects12. Critical to the development of such adaptive/closed-loop DBS technologies is the identification of robust signals on which to base the delivery of variable high-frequency deep brain stimulation. Local field potentials (LFPs), which are recordable through standard DBS electrodes, represent synchronous neuronal discharges within the basal ganglia. Different LFP signatures have been identified in different disorders, as well as in different clinical states within individual disorders. For example, low frequency LFPs in the Alpha/Theta ranges (4-12Hz) are frequently encountered in patients with Dystonia13,14, while both beta (12-30Hz) gamma (60-90Hz) band frequencies may be seen in Parkinson's disease, when the patient is OFF and dyskinetic, respectively15,16. Equally, suppression of these abnormal basal ganglia signals through medication administration or high-frequency DBS correlates with clinical improvement. As such, they represent attractive electrophysiologic biomarkers on which to base adaptive DBS approaches. Until recently, neurophysiological assessments were purely a research tool, as they could only be recorded either intra-operatively or for a short period of time post-operatively using externalised DBS electrodes. However, advances in DBS technology now allow real-time LFP recordings to be simply and seamlessly obtained from fully implanted DBS systems e.g. Medtronic Percept PC. In this study, we will evaluate a cohort of patients with movement disorders and other disorders of basal ganglia circuitry who have implanted DBS systems. Recordings of LFPs and/or non-invasive data such as EEG, limb muscle activation and movement (surface EMG and motion tracking) under various conditions (e.g. voluntary movement, ON/OFF medications, ON/OFF stimulation) will allow us to evaluate their utility as markers of underlying disease phenotype and severity and to assess their potential for use as electrophysiological biomarkers in adaptive DBS approaches. These evaluations in patients with DBS systems with and without LFP-sensing capabilities will take place during a single or multi-day evaluation (depending on patient preference and researcher availability). This study will advance not only the understanding of subcortical physiology in various disorders, but will also provide information about how neurophysiological and behavioural biomarkers can be used to inform personalised, precision closed-loop DBS approaches.

NCT ID: NCT04727658 Not yet recruiting - Essential Tremor Clinical Trials

Linac FRACtionated Radiosurgical THALamotomie in Tremors (FRACTHAL)

FRACTHAL
Start date: March 2021
Phase: Phase 2
Study type: Interventional

Radiosurgical thalamotomy on GammaKnife has been shown to be effective in the management of tremors. However, several teams describe a significant risk of severe neurological complications. In addition, fitting the invasive frame and the need to travel to GammKnife centers often limit access to treatment in this population of elderly patients. Linear accelerators have greatly improved their precision, now reaching that of GammaKnife. A possible alternative is therefore to treat patients on linear accelerators, without an invasive frame. The objective of the FRACTHAL study is to assess the feasibility and safety of treatment of essential and / or parkinsonian tremor by fractional radiosurgical thalamotomy on a linear accelerator. The main hypothesis of the FRACTHAL study is based on the fact that dividing the dose into 3 sessions will both protect healthy tissue around the target while maintaining therapeutic efficacy on the treatment target.

NCT ID: NCT04509349 Not yet recruiting - Essential Tremor Clinical Trials

Alternating Current Stimulation for Essential Tremor

Start date: October 1, 2020
Phase: N/A
Study type: Interventional

Movement disorders are common neurological disorders, characterized by either excess or paucity of movements. Essential tremor (ET) is one of the most common of these disorders, defined as chronic, rhythmic involuntary movements (tremor) that occur primarily during action involving the upper extremities as prominent body site. ET occurs in between 0.4% and 4% of adults below age 60, its prevalence and related impairment of routine daily actions increasing dramatically with age. More than half of patients do not regain functional independence with medications. These patients are offered functional neurosurgical approaches that carry procedural risk or adverse effects secondary to deep electric stimulation of surgical lesioning. Hence, there is a substantial need for alternative, non-invasive therapeutic options for this disabling neurological disorder. Recently, non-invasive neuromodulation applied as transcranial alternating current stimulation (tACS), has emerged as promising for tremor control. In healthy subjects, tACS applied with a high definition (or focused) montage to the primary motor cortex (M1), was found to entrain physiological tremor; in patients with Parkinson's disease, tACS could decrease the amplitude of rest tremor when the stimulation was delivered in phase with, and at the same frequency of, the tremor. Tremor in ET could also be entrained applying ACS to the arm skin's peripheral nerves (transcutaneous ACS), but its effect on tremor amplitude is unknown. METHODS AND POTENTIAL CONTRIBUTION/IMPACT OF THE RESEARCH. The proposed project aims to explore the whole potential of tACS for the tremor suppression in ET. The investigators aim to test the following hypotheses: 1. focused (or high definition, HD) tACS delivered over M1 at the same frequency of the tremor is effective in decreasing tremor amplitude in ET; 2. this effect is strongest when the delivery of tACS is locked to the phase of the tremor expressed by the patient, i.e. administering tACS in a closed-loop modality; 3. transcutaneous ACS in the upper extremities is as effective as tACS applied to the scalp around M1.

NCT ID: NCT04080674 Not yet recruiting - Parkinson's Disease Clinical Trials

Using DBS to Probe Basal Ganglia Dysfunction

Start date: December 1, 2019
Phase:
Study type: Observational

This study will probe the function of collections of neurons deep in the brain termed the basal ganglia It will investigate the role of the basal ganglia in how and why movement is disrupted in conditions like Parkinson's disease, Dystonia and Essential Tremor. Deep brain recording and stimulation will be used to probe the basal ganglia's contribution. Patients with relatively severe movement disorders may have electrodes implanted in the basal ganglia so that stimulation can be delivered chronically as a form of therapy. Studying these patients allows researchers (a) to record brain activity from these electrodes in the basal ganglia during symptoms related to abnormal motor control and (b) to stimulate the same electrodes while patients experience symptoms. Like this they can see what aspects of the activity of groups of nerve cells in the basal ganglia are associated with which symptoms and also establish that these aspects of activity help cause linked symptoms. This means studying patients just after electrode implantation, while the leads from the electrodes may still be available for hooking up to external recording and stimulating devices. Understanding how the activity of groups of nerve cells in the basal ganglia controls movement may help us develop improved treatments.

NCT ID: NCT03562403 Not yet recruiting - Clinical trials for Parkinson Disease, Essential Tremors and Dystonia

DBS in the Treatment of Intractable Movement Disorders

Start date: July 2018
Phase: N/A
Study type: Interventional

The aim of this study is to observe the efficacy of Deep Brain Stimulation in the treatment of Parkinson's disease,Essential Tremors and Dystonia in our locality.

NCT ID: NCT02692183 Not yet recruiting - Essential Tremor Clinical Trials

Mapping Functional Networks of Brain Activity Using EEG in Patients With Essential Tremor or Parkinson Disease Before and After MR-guided Focused Ultrasound Thalamotomy for Tremor

Start date: February 2016
Phase: N/A
Study type: Observational

A cornerstone in PD and ET research is the investigation of neurophysiological changes as potential bio-markers that could help in tracking disease progression and response to therapy. Electroencephalography (EEG) could provide a non-invasive and relatively inexpensive tool for identification of such bio-markers. In this study the investigators will use high-density electroencephalographic (EEG) recordings, in order to develop a platform of sensitive and reliable bio-markers for disease progression and response to MR-guided Focused ultrasound thalamotomy (FUS-T) intervention for tremor.