Comparison of the Efficacy of Double Monopolar Versus Interleaving Stimulation Modes for Pallidal Deep Brain Stimulation

NCT01497639 | Completed DMC

• 1 other identifier: 760906
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to compare the efficacy and the safety profile of the newly introduced interleaving stimulation mode to those of the standard double monopolar stimulation mode during pallidal deep brain stimulation of primary generalized or segmental dystonia.

Conditions

Primary Dystonia

Keywords

dystonia; pallidal stimulation; deep brain stimulation; deep brain stimulation of GPi; GPi; interleaving stimulation

Outcome Measures

Primary Outcomes (1)

• Differences in severity of dystonia

  Differences in severity of dystonia measured by Burke-Fahn-Marsden Dystonia Rating Scale

  7 months

Secondary Outcomes (3)

• Number of treatment responders after three months deep brain stimulation

  7 months

• Health-related quality of life after three months deep brain stimulation

  7 months

• Side-effect profile after three months deep brain stimulation

  7 months

Study Arms (2)

Process 1

ACTIVE COMPARATOR

* Visit 1: Baseline evaluation (maximum 1 week before operation) * Visit 2: Testing of electrodes and subsequent initiation of interleaving stimulation mode (4th postoperative week). * Visit 3 Evaluation and cross-over to double-monopolar stimulation mode (16th postoperative week). * Visit 4 Final evaluation. (28th postoperative week).

Device: Interleaving stimulation mode (Medtronic); Device: Double monopolar stimulation mode (Medtronic)

Process 2

ACTIVE COMPARATOR

* Visit 1: Baseline evaluation (maximum 1 week before operation) * Visit 2: Testing of electrodes and subsequent initiation of double-monopolar stimulation mode (4th postoperative week). * Visit 3 Evaluation and cross-over to interleaving stimulation mode (16th postoperative week). * Visit 4 Final evaluation. (28th postoperative week).

Device: Interleaving stimulation mode (Medtronic); Device: Double monopolar stimulation mode (Medtronic)

Interventions

Interleaving stimulation mode (Medtronic) DEVICE

Interleaving stimulation mode with constant frequency (125 Hz) and pulse-width (120us)parameters 'Interleavingr stimulation mode (Medtronic)'

Also known as: Medtronic Activa RC Interleaving Stimulation Mode

Process 1; Process 2

Double monopolar stimulation mode (Medtronic) DEVICE

Double monopolar stimulation mode with constant frequency (125 Hz) and pulse-width (120us)parameters 'Double monopolar stimulation mode (Medtronic)'

Also known as: Medtronic Activa RC Double Monopolar Stimulation Mode

Process 1; Process 2

Eligibility Criteria

• Age: 7 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• ages of 7 and 75 years
• marked disability owing to primary generalized or segmental dystonia, despite optimal pharmacologic treatment
• disease duration of at least 5 years.

You may not qualify if:

• previous brain surgery;
• cognitive impairment (\< 120 points on the Mattis Dementia Rating Scale)
• moderate-to-severe depression (\> 25 points on the Beck Depression Inventory)
• marked brain atrophy as detected by magnetic resonance imaging
• other medical or psychiatric coexisting disorders that could increase the surgical risk or interfere with completion of the trial

Sponsors & Collaborators

• University of Pecs: lead

Study Sites (1)

Department of Neurology, University of Pécs

Pécs, Baranya, H-7623, Hungary

Location

Related Publications (7)

• Kupsch A, Benecke R, Muller J, Trottenberg T, Schneider GH, Poewe W, Eisner W, Wolters A, Muller JU, Deuschl G, Pinsker MO, Skogseid IM, Roeste GK, Vollmer-Haase J, Brentrup A, Krause M, Tronnier V, Schnitzler A, Voges J, Nikkhah G, Vesper J, Naumann M, Volkmann J; Deep-Brain Stimulation for Dystonia Study Group. Pallidal deep-brain stimulation in primary generalized or segmental dystonia. N Engl J Med. 2006 Nov 9;355(19):1978-90. doi: 10.1056/NEJMoa063618.

  PMID: 17093249 BACKGROUND

• Vidailhet M, Vercueil L, Houeto JL, Krystkowiak P, Benabid AL, Cornu P, Lagrange C, Tezenas du Montcel S, Dormont D, Grand S, Blond S, Detante O, Pillon B, Ardouin C, Agid Y, Destee A, Pollak P; French Stimulation du Pallidum Interne dans la Dystonie (SPIDY) Study Group. Bilateral deep-brain stimulation of the globus pallidus in primary generalized dystonia. N Engl J Med. 2005 Feb 3;352(5):459-67. doi: 10.1056/NEJMoa042187.

  PMID: 15689584 BACKGROUND

• Valldeoriola F, Regidor I, Minguez-Castellanos A, Lezcano E, Garcia-Ruiz P, Rojo A, Salvador A, Castro A, Grandas F, Kulisevsky J, Marti MJ, Martinez-Martin P, Relova L, Rumia J, Camara A, Burguera JA, Linazasoro G, de Val JL, Obeso J, Rodriguez-Oroz MC, Tolosa E; Grupo ESpanol para el EStudio de la EStimulacion PALidal en la DIStonia. Efficacy and safety of pallidal stimulation in primary dystonia: results of the Spanish multicentric study. J Neurol Neurosurg Psychiatry. 2010 Jan;81(1):65-9. doi: 10.1136/jnnp.2009.174342. Epub 2009 Sep 10.

  PMID: 19744963 BACKGROUND

• Vidailhet M, Vercueil L, Houeto JL, Krystkowiak P, Lagrange C, Yelnik J, Bardinet E, Benabid AL, Navarro S, Dormont D, Grand S, Blond S, Ardouin C, Pillon B, Dujardin K, Hahn-Barma V, Agid Y, Destee A, Pollak P; French SPIDY Study Group. Bilateral, pallidal, deep-brain stimulation in primary generalised dystonia: a prospective 3 year follow-up study. Lancet Neurol. 2007 Mar;6(3):223-9. doi: 10.1016/S1474-4422(07)70035-2.

  PMID: 17303528 BACKGROUND

• Kupsch A, Tagliati M, Vidailhet M, Aziz T, Krack P, Moro E, Krauss JK. Early postoperative management of DBS in dystonia: programming, response to stimulation, adverse events, medication changes, evaluations, and troubleshooting. Mov Disord. 2011 Jun;26 Suppl 1:S37-53. doi: 10.1002/mds.23624.

  PMID: 21692111 BACKGROUND

• Kovacs N, Janszky J, Nagy F, Balas I. Changing to interleaving stimulation might improve dystonia in cases not responding to pallidal stimulation. Mov Disord. 2012 Jan;27(1):163-5. doi: 10.1002/mds.23962. Epub 2011 Sep 28. No abstract available.

  PMID: 21956680 BACKGROUND

• Tagliati M, Krack P, Volkmann J, Aziz T, Krauss JK, Kupsch A, Vidailhet AM. Long-Term management of DBS in dystonia: response to stimulation, adverse events, battery changes, and special considerations. Mov Disord. 2011 Jun;26 Suppl 1:S54-62. doi: 10.1002/mds.23535.

  PMID: 21692113 BACKGROUND

MeSH Terms

Conditions

Dystonic Disorders; Dystonia

Condition Hierarchy (Ancestors)

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

Study Officials

• Norbert Kovacs, MD, PhD

  Associate professor, Department of Neurology, University of Pecs

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, specialist in neurology and movement disorders, Department of Neurology

Study Record Dates

• First Submitted: December 14, 2011
• First Posted: December 22, 2011
• Study Start: March 1, 2012
• Primary Completion: June 7, 2018
• Study Completion: June 7, 2018
• Last Updated: November 26, 2018

Record last verified: 2018-11

Locations

HU (1)