Primary DystoniaNCT01497639
Comparison of the Efficacy of Double Monopolar Versus Interleaving Stimulation Modes for Pallidal Deep Brain Stimulation
A study testing Interleaving stimulation mode (Medtronic) and Double monopolar stimulation mode (Medtronic) in people with Primary Dystonia, run by University of Pecs at 1 site in Hungary.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 75 years
- Conditions the study is for
- Primary Dystonia
- What is being tested?
- Interleaving stimulation mode (Medtronic) and Double monopolar stimulation mode (Medtronic)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteHungary
- Study dates
- Mar 2012to 7 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Hungary1 site
Department of Neurology, University of Pécs
Pécs, Baranya, H-7623
About this study
Official title: Comparison of the Efficacy of Double Monopolar Versus Interleaving Stimulation Modes for the Deep Brain Stimulation Treatment of Primary Generalized or Segmental Dystonia
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.
Read the detailed description
Background:
For the treatment of drug-refractory dystonia, bilateral pallidal deep brain stimulation (GPi-DBS) is proven to be an efficient option. On average, 40-55% improvement on dystonia rating scales (DRS) could be achieved according to the results of multicenter trials lasting for years. However, a considerable portion (10-25%) of the patients experience minimal alleviation despite of good electrode placement. These patients can be regarded as non-responders to GPi-DBS defined as having either limited improvement (< 25% on DRS) or worsening. Besides adjusting the amplitude, frequency or pulse-width of stimulation, one can change the electrode configuration from the commonly applied single monopolar stimulation mode (one contact on the electrode is negative) to either double monopolar stimulation (two -usually adjacent- negative contacts on the electrode are stimulated with same amplitude and pulse-width values) or bipolar stimulation mode (one contact on the electrode is positive) in case of unsatisfactory outcomes. Although these techniques had been utilized in multicenter trials, non-responsiveness to GPi-DBS did occur. Recently the investigators have reported in the Movement Disorders that the newly introduced interleaving stimulation mode was superior to single or double monopolar stimulation in four patients who had initially (6-12 months after implantation) limited response to GPi DBS.
Aims of the study:
To systematically compare the efficacy and the side-effect profile of double monopolar stimulation mode to those of interleaving stimulation mode in a prospective, randomized, double-blind, and cross-over study.
Methods:
The investigators would enroll 20-25 patients with drug refractory segmental or generalized primary dystonia undergoing bilateral GPi-DBS implantation within a 2-3 year time frame. The inclusion and exclusion criteria would follow those of the study of Kupsch et al.
- Conditions
- Primary Dystonia
- Being tested
- Interleaving stimulation mode (Medtronic), Double monopolar stimulation mode (Medtronic)
- Keywords
- dystonia, pallidal stimulation, deep brain stimulation, deep brain stimulation of GPi, GPi, interleaving stimulation
- Medical subject headings
- Dystonic Disorders, Dystonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interleaving stimulation mode (Medtronic)Device
Also called Medtronic Activa RC Interleaving Stimulation Mode
Interleaving stimulation mode with constant frequency (125 Hz) and pulse-width (120us)parameters 'Interleavingr stimulation mode (Medtronic)'
Double monopolar stimulation mode (Medtronic)Device
Also called Medtronic Activa RC Double Monopolar Stimulation Mode
Double monopolar stimulation mode with constant frequency (125 Hz) and pulse-width (120us)parameters 'Double monopolar stimulation mode (Medtronic)'
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Device: Interleaving stimulation mode (Medtronic); Device: Double monopolar stimulation mode (Medtronic) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in severity of dystonia
Differences in severity of dystonia measured by Burke-Fahn-Marsden Dystonia Rating Scale
Measured: 7 months
Secondary outcomes (3)
Number of treatment responders after three months deep brain stimulation
Differences in number of treatment responders (at least 25% improvement on Burke-Fahn-Marsden Dystonia Rating Scale compared to baseline)
Measured: 7 months
Health-related quality of life after three months deep brain stimulation
Differences in health-related quality of life measured by EQ-5D and SF-36 scales
Measured: 7 months
Side-effect profile after three months deep brain stimulation
Differences in side-effect profile measured by stuctured deep brain stimulation-related side-effect questionnaire
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2011 (estimated)
- Study startMar 2012
- Primary completion7 Jun 2018
- Study completion7 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Primary DystoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pecs
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Norbert Kovacs, University of Pecs
- Investigators
- Norbert Kovacs, MD, PhD, Principal investigator, Associate professor, Department of Neurology, University of Pecs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01497639
- Sponsor's protocol ID
- 760906
- Status last verified
- Nov 2018
- First submitted
- 14 Dec 2011
- Last updated
- 26 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 17093249Vidailhet 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.
PubMed 15689584Valldeoriola 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.
PubMed 19744963Vidailhet 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.
PubMed 17303528Kupsch 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.
PubMed 21692111Kovacs 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.
PubMed 21956680Tagliati 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.
PubMed 21692113
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Double Monopolar Versus Interleaving Stimulation Modes for the Deep Brain Stimulation Treatment of Primary Generalized or Segmental Dystonia
- ClinicalTrials.gov ID
- NCT01497639
- Acronym / sponsor ID
- 760906
- Conditions
- Primary Dystonia
- Keywords
- dystonia, pallidal stimulation, deep brain stimulation, deep brain stimulation of GPi, GPi, interleaving stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of PecsUniversity, hospital or other
- Study start
- Mar 2012 (actual)
- Primary completion
- 7 Jun 2018 (actual)
- Study completion
- 7 Jun 2018 (actual)
- First posted
- 22 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background:
For the treatment of drug-refractory dystonia, bilateral pallidal deep brain stimulation (GPi-DBS) is proven to be an efficient option. On average, 40-55% improvement on dystonia rating scales (DRS) could be achieved according to the results of multicenter trials lasting for years. However, a considerable portion (10-25%) of the patients experience minimal alleviation despite of good electrode placement. These patients can be regarded as non-responders to GPi-DBS defined as having either limited improvement (< 25% on DRS) or worsening. Besides adjusting the amplitude, frequency or pulse-width of stimulation, one can change the electrode configuration from the commonly applied single monopolar stimulation mode (one contact on the electrode is negative) to either double monopolar stimulation (two -usually adjacent- negative contacts on the electrode are stimulated with same amplitude and pulse-width values) or bipolar stimulation mode (one contact on the electrode is positive) in case of unsatisfactory outcomes. Although these techniques had been utilized in multicenter trials, non-responsiveness to GPi-DBS did occur. Recently the investigators have reported in the Movement Disorders that the newly introduced interleaving stimulation mode was superior to single or double monopolar stimulation in four patients who had initially (6-12 months after implantation) limited response to GPi DBS.
Aims of the study:
To systematically compare the efficacy and the side-effect profile of double monopolar stimulation mode to those of interleaving stimulation mode in a prospective, randomized, double-blind, and cross-over study.
Methods:
The investigators would enroll 20-25 patients with drug refractory segmental or generalized primary dystonia undergoing bilateral GPi-DBS implantation within a 2-3 year time frame. The inclusion and exclusion criteria would follow those of the study of Kupsch et al.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Process 1 | Active comparator | Device: Interleaving stimulation mode (Medtronic), Device: Double monopolar stimulation mode (Medtronic)* 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). |
| Process 2 | Active comparator | Device: Interleaving stimulation mode (Medtronic), Device: Double monopolar stimulation mode (Medtronic)* 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). |
Who may qualify
- Ages
- 7 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interleaving stimulation mode (Medtronic)Also: Medtronic Activa RC Interleaving Stimulation ModeInterleaving stimulation mode with constant frequency (125 Hz) and pulse-width (120us)parameters 'Interleavingr stimulation mode (Medtronic)' | Device | Process 1, Process 2 |
| Double monopolar stimulation mode (Medtronic)Also: Medtronic Activa RC Double Monopolar Stimulation ModeDouble monopolar stimulation mode with constant frequency (125 Hz) and pulse-width (120us)parameters 'Double monopolar stimulation mode (Medtronic)' | Device | Process 1, Process 2 |
Primary outcome
Differences in severity of dystonia
Time frame: 7 months
Differences in severity of dystonia measured by Burke-Fahn-Marsden Dystonia Rating Scale
3 secondary outcomes
Number of treatment responders after three months deep brain stimulation
Time frame: 7 months
Health-related quality of life after three months deep brain stimulation
Time frame: 7 months
Side-effect profile after three months deep brain stimulation
Time frame: 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2018.
- Background: PubMed 17093249Kupsch 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.
- Background: PubMed 15689584Vidailhet 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.
- Background: PubMed 19744963Valldeoriola 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.
- Background: PubMed 17303528Vidailhet 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.
- Background: PubMed 21692111Kupsch 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.
- Background: PubMed 21956680Kovacs 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.
- Background: PubMed 21692113Tagliati 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Norbert Kovacs, MD, PhD principal investigator
Associate professor, Department of Neurology, University of Pecs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interleaving stimulation mode (Medtronic) and Double monopolar stimulation mode (Medtronic) in people with Primary Dystonia, run by University of Pecs at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in severity of dystonia (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01497639, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2018.