SANTE - Stimulation of the Anterior Nucleus of the Thalamus for Epilepsy

NCT00101933 | Completed Phase 3 Results DMC

• 1 other identifier: 1604
• Study Type: interventional
• Target: 157
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this research is to study the safety and effectiveness of bilateral stimulation of the anterior nucleus of the thalamus as adjunctive therapy for reducing the frequency of seizures in adults diagnosed with epilepsy characterized by partial-onset seizures, with or without secondary generalization, that are refractory to antiepileptic medications.

Conditions

Epilepsy

Keywords

Deep brain stimulation, DBS, SANTE

Outcome Measures

Primary Outcomes (2)

• Primary Analysis: Change in Seizure Rate

  A protocol-prespecified generalized estimating equations (GEE) analysis was used to evaluate the treatment effect on seizure frequency. The final GEE model for the primary objective evaluation included treatment effect, log of the baseline seizure count, log of age, visit (categorical), treatment-by-visit interaction (categorical), and the offset (the number of days the diary was recorded in each month).

  Through the end of the three-month blinded phase

• Alternative Primary Analysis: Change in Seizure Rate

  A generalized estimating equations (GEE) analysis was used to evaluate the treatment effect on seizure frequency. With one outlier subject removed, the GEE model for this alternative analysis included treatment effect, log of the baseline seizure count, log of age, visit (categorical), and the offset (the number of days the diary was recorded in each month).

  Through the end of the three-month blinded phase

Secondary Outcomes (6)

• Adverse Events Experienced With the Medtronic DBS System

  Through Year 2 of the long-term follow-up phase

• Incidence of Sudden Unexplained Death in Epilepsy (SUDEP)

  Inclusive of all study follow-up after device implantation (mean follow-up 3.7 years)

• Seizure Responder Rate

  Through the end of the three-month blinded phase

• Change in Percentage of Days Seizure-free

  Through the end of the three-month blinded phase

• Percentage Change in the Maximum Length of Seizure-free Intervals

  Through the end of the three-month blinded phase

Other Outcomes (1)

• Change in Most Severe Seizures

  Through the end of the three-month blinded phase

Study Arms (2)

1

EXPERIMENTAL

Active Stimulation

Device: Medtronic DBS Therapy for epilepsy

2

SHAM COMPARATOR

No Stimulation

Device: Medtronic DBS Therapy for epilepsy

Interventions

Medtronic DBS Therapy for epilepsy DEVICE

Stimulation On

1

Eligibility Criteria

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

You may not qualify if:

• Partial-onset seizures with or without secondary generalization. The final determination shall be made by the Investigator based on a clinical description of the seizures and previous diagnostic testing that includes, at a minimum, video/clinical EEG that captured at least one ictal event.
• Anticipated average of 6 or more partial-onset seizures (with or without secondary generalized seizures) per month during the Baseline Phase, with no more than 30 days between seizures during the Baseline Phase.
• Refractory to antiepileptic drugs (AEDs). Patients will be considered refractory if they have failed at least three AEDs due to lack of efficacy.
• Receiving one to four currently marketed AEDs
• Be between 18 and 65 years of age at the time of lead implant
• Multilobar (\>3 different lobes) anatomic areas of seizure onset
• Symptomatic generalized epilepsy
• Previous diagnosis of psychogenic/non-epileptic seizures
• Presence of implanted electrical stimulation medical device anywhere in the body (e.g., cardiac pacemakers, spinal cord stimulator) or any metallic implants in the head (e.g., aneurysm clip, cochlear implant). Vagal nerve stimulators are allowed if the device has been turned off for at least 30 days prior to the Baseline Week -12 visit and the patient agrees to have the generator explanted prior to or at the time of the Kinetra Neurostimulator implant.

Sponsors & Collaborators

• MedtronicNeuro: lead

Related Publications (4)

• Miller PM, Gross RE. Wire tethering or 'bowstringing' as a long-term hardware-related complication of deep brain stimulation. Stereotact Funct Neurosurg. 2009;87(6):353-9. doi: 10.1159/000236369. Epub 2009 Sep 10.

  PMID: 19752594 BACKGROUND

• Fisher R, Salanova V, Witt T, Worth R, Henry T, Gross R, Oommen K, Osorio I, Nazzaro J, Labar D, Kaplitt M, Sperling M, Sandok E, Neal J, Handforth A, Stern J, DeSalles A, Chung S, Shetter A, Bergen D, Bakay R, Henderson J, French J, Baltuch G, Rosenfeld W, Youkilis A, Marks W, Garcia P, Barbaro N, Fountain N, Bazil C, Goodman R, McKhann G, Babu Krishnamurthy K, Papavassiliou S, Epstein C, Pollard J, Tonder L, Grebin J, Coffey R, Graves N; SANTE Study Group. Electrical stimulation of the anterior nucleus of thalamus for treatment of refractory epilepsy. Epilepsia. 2010 May;51(5):899-908. doi: 10.1111/j.1528-1167.2010.02536.x. Epub 2010 Mar 17.

  PMID: 20331461 RESULT

• Troster AI, Meador KJ, Irwin CP, Fisher RS; SANTE Study Group. Memory and mood outcomes after anterior thalamic stimulation for refractory partial epilepsy. Seizure. 2017 Feb;45:133-141. doi: 10.1016/j.seizure.2016.12.014. Epub 2016 Dec 23.

  PMID: 28061418 RESULT

• Salanova V, Witt T, Worth R, Henry TR, Gross RE, Nazzaro JM, Labar D, Sperling MR, Sharan A, Sandok E, Handforth A, Stern JM, Chung S, Henderson JM, French J, Baltuch G, Rosenfeld WE, Garcia P, Barbaro NM, Fountain NB, Elias WJ, Goodman RR, Pollard JR, Troster AI, Irwin CP, Lambrecht K, Graves N, Fisher R; SANTE Study Group. Long-term efficacy and safety of thalamic stimulation for drug-resistant partial epilepsy. Neurology. 2015 Mar 10;84(10):1017-25. doi: 10.1212/WNL.0000000000001334. Epub 2015 Feb 6.

  PMID: 25663221 RESULT

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Limitations and Caveats

No limitations leading to unreliable data were identified.

Results Point of Contact

• Title: Jim Vollhaber, Clinical Study Manager
• Organization: Medtronic Neuromodulation

medtronicneurotrials@medtronic.com

763-526-8093

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2005
• First Posted: January 19, 2005
• Study Start: December 1, 2003
• Primary Completion: June 1, 2008
• Study Completion: October 1, 2017
• Last Updated: March 22, 2018
• Results First Posted: January 21, 2013

Record last verified: 2018-02