Essential Tremor
Conditions
Keywords
Essential Tremor, Deep Brain Stimulation
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.
Interventions
DEVICEAbbott St Jude Medical Infinity 7 neurostimulator
The stimulator has the capability to deliver both continuous and cyclical modes of stimulation which is being investigated in this study
Sponsors
King's College Hospital NHS Trust
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
This study adopts a blind design. Only the programmer is aware of the randomisation details and the parameters will be kept separately in order to keep others blind about the intervention. Unblinding of the study will occur at the 3rd month of the study.
Intervention model description
Patients will be randomized into 2 groups with either cyclical or continuous stimulation. Patients will cross-over to the 2nd mode of stimulation after 1 month and then continued on the preferred mode of stimulation for the 3rd month. Open label follow-up starts at this point and continues for another 9 months.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
Countries
United Kingdom
Contacts
Primary ContactKantharuby Tambirajoo, MD
Outcome results
None listed