Cyclic Deep Brain Stimulation in Essential Tremor

King's College Hospital NHS Trust

Status: Unknown

Conditions: Essential Tremor

Treatments: Device: Abbott St Jude Medical Infinity 7 neurostimulator

Study type: Interventional

Funder types: Other

Identifiers

NCT04260971

KCH20-025

270731 (Other Identifier)

Details and patient eligibility

About

The aim of the study is to prove the efficacy and safety of cyclical deep brain stimulation (DBS) in patients with essential tremor, and demonstrate non-inferiority of cyclical DBS on tremor control when compared to continuous stimulation.

Full description

This study is a prospective, randomized, double-blind cross-over trials. Patients will be randomized into two groups in a cross-over fashion to have either continuous or cyclical stimulation for a total of three months. Following this, the trial will be unblinded and open-label follow up will continue for another nine months. Device use as per standard practice continues after the end of the trial.

If the hypothesis is proven correct, this will provide proof of concept that cyclical stimulation for the treatment of essential tremor results in improved battery life, reduced number of operations for battery changes, reduction in stimulation side-effects and enhancing quality of life.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Participant is at least 18 years of age
2. Participant has confirmed diagnosis of medically-refractory essential tremor
3. Participant meets criteria for implantation of DBS system
4. Participant understands the study requirements and treatments procedures and provides informed consent before any study-specific tests or procedures are performed

Exclusion criteria

1. Participant meets any contraindications for implantation of DBS system
2. Participant is undergoing or has had previous thalamic stimulation either in a research trial or with a permanent implant
3. Participant is unwilling or unable to comply with all study required follow-up evaluations

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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15 participants in 2 patient groups

Cyclical Stimulation

Experimental group

Description:

This group will undergo cyclical stimulation mode of stimulation

Treatment:

Device: Abbott St Jude Medical Infinity 7 neurostimulator

Continuous Stimulation

Active Comparator group

Description:

This group will undergo the standard continuous mode of stimulation

Treatment:

Device: Abbott St Jude Medical Infinity 7 neurostimulator