A Controlled Comparison of Two DBS Targets for Upper Extremity Action Tremor

NCT03156517 | Completed

• 1 other identifier: 2013/1013
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Action tremor of the arms can be an invalidizing symptom of diseases such as Essential Tremor, Dystonic Tremor, Parkinson's disease and Multiple Sclerosis. In this study we compare the efficacy and safety of two different brain targets for deep brain stimulation (DBS) that both are known to reduce action tremor of the arms. These two targets are called the VIM nucleus of the thalamus (VIM) and the posterior subthalamic area (PSA), which includes the Zona Incerta. Both targets can be reached by one lead (wirh four electrode contact). Patients that are found eligible for DBS because of severe action tremor of the arms are invited to participate. After randomization, half of them are stimulated first in the VIM for 3 months and then in the PSA for 3 months, and the other half first in the PSA and then VIM for 3 months each. Tremor severity is scored on a clinical quantitative scale at baseline and at the end of each of these two 3-month periods, and eventual side-effects are registered. The best target is then selected and after another 6 months scoring is repeated. We intend to provide robust data about whether one of the two targets is superior to the other both regarding ability to reduce tremor efficiently and to avoid or minimize side-effects, or if there is no significant difference between the two targets. We also carefully check the exact position of the active electrode contact in the brain and compare this with efficacy and safety evaluations. Long-term follow-up is planned after 3, 5, 7 and 10 years.

Conditions

Action Tremor

Keywords

Treatment; Deep Brain Stimulation; VIM Nucleus of the Thalamus; Posterior Subthalamic Area; Zona Incerta; Efficacy; Safety

Outcome Measures

Primary Outcomes (1)

• Upper extremity FTM-Tremor Rating Scale score change with VIM versus PSA-stimulation

  The difference in the change from baseline to the end of each of the two 3-month randomized cross-over periods, in tremor of the contralateral upper limb(s), as evaluated by items 5,6,10-14 and 16-21 in the Fahn-Tolosa-Marin (FTM)-score with VIM- versus PSA-stimulation.

  3 months (+/- 2 weeks) and 6 months (+/- 2 weeks) after operation

Secondary Outcomes (3)

• FTM-Tremor rating Scale score changes from baseline to 1-yr (all body regions)

  1 year (+/- 4 weeks) after surgery

• Change of patient evaluated scores at 1 year of stimulation (QUEST and VAS Global Burden Disease Burden (Tremor-burden)

  1 year (+/- 4 weeks) after surgery

• Frequency of serious adverse events

  Comparing the two randomization periods (;at 3 and 6 months), and up to 1 year of stimulation

Study Arms (2)

Deep Brain Stimulation in VIM

ACTIVE COMPARATOR

Patients receive stimulation in the VIM-nucleus of the thalamus

Device: Deep Brain Stimulation

Deep Brain Stimulation in PSA

ACTIVE COMPARATOR

Patients receive stimulation in the posterior subthalamic area

Device: Deep Brain Stimulation

Interventions

Deep Brain Stimulation DEVICE

Deep Brain Stimulation in PSA; Deep Brain Stimulation in VIM

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Min 5-yr duration chronic action tremor of upper limb(s), w/ or w/out tremor of head/neck, trunk, lower limbs, who have insufficient relief from adequate trials of recommended medications. The arm tremor must be so severe that it interferes with the patient's work performance or activities of daily living, such as drinking/eating, dressing/hygiene, and/or writing. Clinical diagnosis (according to criteria defined by the Consensus Statement of the Movement Disorders Society) include Essential Tremor, Dystonic Tremor, Cerebellar Tremor- idiopathic or secondary (to e.g.MS or SCA), or severe PD tremor (who are not eligible for DBS of the subthalamic nucleus).

You may not qualify if:

• Brain MRI showing so marked general atrophy, or supra-tentorial white matter changes, that the safety of the procedure is affected. Co-morbidity of dementia or other severe neuropsychiatric disorder (major depression or anxiety disorder, active/recent psychosis, drug or other substance abuse). Increased risk of bleeding, cancer at advanced/not stabilized stage, other severe co-morbidity (e.g. With chronic pain, short life expectancy,). Other surgical contraindications.

Sponsors & Collaborators

• Oslo University Hospital: lead
• South-Eastern Norway Regional Health Authority: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, Norway

Location

Related Links

• Annual eReport to the South-Eastern Norway Health Authority

MeSH Terms

Conditions

Tremor

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Study Officials

• Inger Marie Skogseid, MDPhD

  Oslo University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Both the doctor who assesses the primary outcome measures at 3 and 6 months and the participant are unaware of which of the two targets is stimulated in the two randomization periods.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant, MDPhD

Model Details: Randomized allocation of half the patients to be stimulated the first 3 months in the VIM-nucleus of the thalamus (VIM) and then 3 months in the posterior subthalamic area (PSA), and for the other half the first 3 months in the PSA and the next 3 months in the VIM

Study Record Dates

• First Submitted: May 15, 2017
• First Posted: May 17, 2017
• Study Start: April 20, 2014
• Primary Completion: June 3, 2019
• Study Completion: December 5, 2019
• Last Updated: October 27, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)