Cyclic Deep Brain Stimulation in Essential Tremor

Not Applicable

• Conditions: Essential Tremor
• Interventions: Device: Abbott St Jude Medical Infinity 7 neurostimulator

• Registration Number: NCT04260971
• Lead Sponsor: King's College Hospital NHS Trust

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2020-02-06
• Study First Submitted QC: 2020-02-06
• Study First Posted: 2020-02-07
• Study Start: 2020-02-25
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-01
• Last Update Posted: 2021-09-02
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cyclical Stimulation	Abbott St Jude Medical Infinity 7 neurostimulator	This group will undergo cyclical stimulation mode of stimulation
Continuous Stimulation	Abbott St Jude Medical Infinity 7 neurostimulator	This group will undergo the standard continuous mode of stimulation

Primary Outcome Measures

Name	Time	Method
Fahn-Tolosa-Marin Tremor Rating Scale - total score difference	6 months compared to baseline	Change in Fahn-Tolosa-Marin tremor rating scale at 6 months compared to baseline. Minimum score is 0 and maximum score is 84. Higher scores indicate worse tremor control

Secondary Outcome Measures

Name	Time	Method
EuroQol five dimensions questionnaire (EQ-5D) difference	6 months post activation compared to baseline	The total score of EQ-5D questionnaire at 6 months compared to baseline. Each dimension of the questionnaire has a minimum score of 1 and a maximum score of 5. Higher composite scores indicate increased levels of perceived problems
Clinical Global Impression of Change (CGI) difference	6 months post activation compared to baseline	The difference in Clinical Global Impression of change outcome at 6 months compared to baseline
Quality of Life in Essential Tremor (QUEST) questionnaire difference	6 months post activation compared to baseline	The total score of Quality of Life in Essential Tremor questionnaire at 6 months compared to baseline. Minimum score is 0 and maximum score is 120 with higher scores indicating worse quality of life due to tremor
Satisfaction with Treatment (SWT) questionnaire difference	6 months post activation compared to baseline	The difference in Satisfaction with Treatment outcomes at 6 months compared to baseline
Implantable Pulse Generator (IPG) power consumption and longevity	6 months compared to baseline	Total amount of implantable pulse generator consumption used compared between the 2 groups
Beck's Depression Index questionnaire difference	6 months post activation compared to baseline	The total score of Beck's Depression Index questionnaire at 6 months compared to baseline. The minimum score is 0 and maximum score is 63. Higher scores indicate increasing severity of depression

Trial Locations

Locations (1)

King's College Hospital NHS Foundation Trust; 🇬🇧 London, United Kingdom