Parkinson's DiseasePhase 4DEXPROPARNCT02256319

Dexmedetomidine vs Propofol on the Recordings of Deep Brain Activity Measured Through Implanted Stimulators

A Phase 4 study testing Dexmedetomidine and Propofol in people with Parkinson's Disease, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This clinical trial has been designed to study and compare changes in deep brain activity (field potentials) in Parkinson's disease (PD) patients while awake, and during sedation with dexmedetomidine or propofol. The recording is made through a deep brain stimulation (DBS) electrode implanted for PD management. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Parkinson's Disease
What is being tested?: Dexmedetomidine and Propofol
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteSpain
Study dates: Sep 2014to Dec 2015
Phase: Phase 4
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Capacity to understand, consent and commit for the three phases of the study.
Older than 18 years old.
The patient is scheduled for DBS electrode placement for PD treatment by his neurologist.

Who cannot join

Allergy or hypersensibility to dexmedetomidine or propofol
Cardiac blockade (types 2 and 3) without an implanted pacemaker
Low blood pressure (mean < 60 mmHg) or symptoms of low cardiac output.
Severe cerebrovascular disease.
Pregnancy or nursing mothers.

Trial locations and contacts

1 site in 1 country.

Spain1 site

University of Navarra Clinic
Pamplona, Navarre, 31008

Other trials in Spain

About this study

Official title: Effects of Dexmedetomidine vs Propofol on the Recordings of Deep Brain Activity (Local Field Potentials) Measured Through Implanted Stimulators

The investigators hypothesize that dexmedetomidine produces fewer changes as compared to propofol, and that those changes are consistent and recognizable when compared to activity in patients not exposed to any sedation. Typification of those changes would in the future allow for patients to undergo this surgery comfortably while not compromising the quality of the recording and of the final clinical outcome. The principal variable analyzed is the signal's power in each of the frequency bands, absolute and relative. The analysis will include usual clinical methods such as rapid Fourier transform (FFT) and window fast Fourier transform (WFFT), wavelet analysis, Gabor, and coherence.

Read the detailed description

Comparative clinical trial, non blinded, controlled and sequential, evaluating the effects of propofol and dexmedetomidine in the basal ganglia of PD patients through a DBS electrode.

It is a phase IV clinical trial evaluating the effects of a drug outside the approved.

The study takes part in three phases:

DBS placement under sedation with dexmedetomidine at 0.2 μg/kg/h. This will be called "dexmedetomidine record".
Four days later and with no sedation, a recording will be registered in one of the specialized electrically isolated rooms at the Neurophysiology Department. This will be dubbed "basal recording". The equipment used is also the standard one used for routine postoperative recordings.
5 days after the initial surgery, and following the protocol in place for these procedures, the tunnelization and battery placement will take place. This is done under general anaesthesia. During anaesthetic induction, the patient is exposed to incremental doses of propofol. Different plasmatic concentrations will be targeted using the mathematical model in the target controlled infusion (TCI) pump. These recordings will be called "propofol at a 0.5, 1, 1.5, 2, 2.5 μg/mL".

Conditions: Parkinson's Disease
Being tested: Dexmedetomidine, Propofol
Keywords: Deep brain stimulation, Dexmedetomidine, Propofol
Medical subject headings: Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DexmedetomidineDrug
Also called (S)-4-[1-(2,3-Dimethylphenyl)ethyl]-3H-imidazole
Patients will receive a loading dose of 1 µg/kg in 10 min before starting the surgery. The maintenance dose will be 0.2-1 µg/kg/h for a Ramsey Sedation Score of 3-4 during the surgery´s preparation. It will be reduced to 0.2 µg/kg/h 15 min before starting the microelectrode recording for a Ramsey Sedation Score of 2. After the placement of the deep brain stimulator we will record the local field potentials activity. In addition, the subscales of rigidity, tremor and bradykinesia of the Unified Parkinson's Disease Rating Scale (UPDRS-III) score will be evaluated. Once the deep brain stimulator recording and neurologic exploration will be over patients will receive a maintenance dose 0.2-1 µg/kg/h until the end of the surgery. It will be stopped to transfer the patient to the ICU.
PropofolDrug
Also called 2,6-diisopropylphenol
The target doses are 0.5, 1, 1.5, 2 and 2.5 µg/kg. For its administration we will use the TCI (target controlled infusion) system. After programming each dose we will wait until the plasma and brain concentration of propofol are stabilized in this target and then we will record the local field potentials activity through the DBS. In addition, the subscales of rigidity, tremor and bradykinesia of the UPDRS-III score will be evaluated.

Study groups in NCT02256319
Study group	Role	What they receive
Dexmedetomidine recording	Experimental	Recording registered through the deep brain stimulation electrodes with dexmedetomidine at 0.2 μg/kg/h. Receives: Drug: Dexmedetomidine
Propofol recording	Active comparator	Recording registered through the deep brain stimulation electrodes with propofol at plasmatic levels of 0.5, 1, 1.5, 2, 2.5 μg/mL. Receives: Drug: Propofol
Basal recording	No intervention	Recording registered through the deep brain stimulation electrodes with no sedation .

What is being measured

The primary outcome is the main question the study is designed to answer.

Signal power of the local field potentials.
Signal power separated in bandwidth (theta, slow beta, fast beta, gamma, high frequency); absolute and relative. The comparison will be made between the different measurements: dexmedetomidine, basal and propofol.
Measured: 5 minutes for each record

Secondary outcomes (1)

UPDRS-III score
Changes in UPDRS-III score with dexmedetomidine and propofol
Measured: 2 minutes for each score

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2014Dec 2015

First posted3 Oct 2014 (estimated)
Study startSep 2014
Primary completionDec 2015
Study completionDec 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (15)Papers the sponsor has linked to this study.
Other trials for Parkinson's DiseaseStudies 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 4
Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02256319
Sponsor's protocol ID: DEXPROPAR
Acronym: DEXPROPAR
Status last verified: Feb 2015
First submitted: 30 Sep 2014
Last updated: 18 Dec 2015
Results posted: No
Data monitoring committee: Yes

Publications

Krack P, Batir A, Van Blercom N, Chabardes S, Fraix V, Ardouin C, Koudsie A, Limousin PD, Benazzouz A, LeBas JF, Benabid AL, Pollak P. Five-year follow-up of bilateral stimulation of the subthalamic nucleus in advanced Parkinson's disease. N Engl J Med. 2003 Nov 13;349(20):1925-34. doi: 10.1056/NEJMoa035275.
PubMed 14614167
Hamani C, Richter E, Schwalb JM, Lozano AM. Bilateral subthalamic nucleus stimulation for Parkinson's disease: a systematic review of the clinical literature. Neurosurgery. 2005 Jun;56(6):1313-21; discussion 1321-4. doi: 10.1227/01.neu.0000159714.28232.c4.
PubMed 15918948
Poon CC, Irwin MG. Anaesthesia for deep brain stimulation and in patients with implanted neurostimulator devices. Br J Anaesth. 2009 Aug;103(2):152-65. doi: 10.1093/bja/aep179. Epub 2009 Jun 25.
PubMed 19556271
Sassi M, Zekaj E, Grotta A, Pollini A, Pellanda A, Borroni M, Pacchetti C, Menghetti C, Porta M, Servello D. Safety in the use of dexmedetomidine (precedex) for deep brain stimulation surgery: our experience in 23 randomized patients. Neuromodulation. 2013 Sep-Oct;16(5):401-6; discussion 406. doi: 10.1111/j.1525-1403.2012.00483.x. Epub 2012 Jul 10.
PubMed 22780449
Rozet I, Muangman S, Vavilala MS, Lee LA, Souter MJ, Domino KJ, Slimp JC, Goodkin R, Lam AM. Clinical experience with dexmedetomidine for implantation of deep brain stimulators in Parkinson's disease. Anesth Analg. 2006 Nov;103(5):1224-8. doi: 10.1213/01.ane.0000239331.53085.94.
PubMed 17056959
Reck C, Florin E, Wojtecki L, Krause H, Groiss S, Voges J, Maarouf M, Sturm V, Schnitzler A, Timmermann L. Characterisation of tremor-associated local field potentials in the subthalamic nucleus in Parkinson's disease. Eur J Neurosci. 2009 Feb;29(3):599-612. doi: 10.1111/j.1460-9568.2008.06597.x. Epub 2009 Jan 28.
PubMed 19187268
Rodriguez-Oroz MC, Lopez-Azcarate J, Garcia-Garcia D, Alegre M, Toledo J, Valencia M, Guridi J, Artieda J, Obeso JA. Involvement of the subthalamic nucleus in impulse control disorders associated with Parkinson's disease. Brain. 2011 Jan;134(Pt 1):36-49. doi: 10.1093/brain/awq301. Epub 2010 Nov 8.
PubMed 21059746
Urrestarazu E, Iriarte J, Alegre M, Clavero P, Rodriguez-Oroz MC, Guridi J, Obeso JA, Artieda J. Beta activity in the subthalamic nucleus during sleep in patients with Parkinson's disease. Mov Disord. 2009 Jan 30;24(2):254-60. doi: 10.1002/mds.22351.
PubMed 18951542
Rodriguez-Oroz MC, Obeso JA, Lang AE, Houeto JL, Pollak P, Rehncrona S, Kulisevsky J, Albanese A, Volkmann J, Hariz MI, Quinn NP, Speelman JD, Guridi J, Zamarbide I, Gironell A, Molet J, Pascual-Sedano B, Pidoux B, Bonnet AM, Agid Y, Xie J, Benabid AL, Lozano AM, Saint-Cyr J, Romito L, Contarino MF, Scerrati M, Fraix V, Van Blercom N. Bilateral deep brain stimulation in Parkinson's disease: a multicentre study with 4 years follow-up. Brain. 2005 Oct;128(Pt 10):2240-9. doi: 10.1093/brain/awh571. Epub 2005 Jun 23.
PubMed 15975946
Venkatraghavan L, Manninen P. Anesthesia for deep brain stimulation. Curr Opin Anaesthesiol. 2011 Oct;24(5):495-9. doi: 10.1097/ACO.0b013e32834a894c.
PubMed 21772140
Venkatraghavan L, Luciano M, Manninen P. Review article: anesthetic management of patients undergoing deep brain stimulator insertion. Anesth Analg. 2010 Apr 1;110(4):1138-45. doi: 10.1213/ANE.0b013e3181d2a782. Epub 2010 Feb 8.
PubMed 20142347
Raz A, Eimerl D, Zaidel A, Bergman H, Israel Z. Propofol decreases neuronal population spiking activity in the subthalamic nucleus of Parkinsonian patients. Anesth Analg. 2010 Nov;111(5):1285-9. doi: 10.1213/ANE.0b013e3181f565f2. Epub 2010 Sep 14.
PubMed 20841416
Steigerwald F, Hinz L, Pinsker MO, Herzog J, Stiller RU, Kopper F, Mehdorn HM, Deuschl G, Volkmann J. Effect of propofol anesthesia on pallidal neuronal discharges in generalized dystonia. Neurosci Lett. 2005 Oct 7;386(3):156-9. doi: 10.1016/j.neulet.2005.06.012.
PubMed 16024174
Rozet I. Anesthesia for functional neurosurgery: the role of dexmedetomidine. Curr Opin Anaesthesiol. 2008 Oct;21(5):537-43. doi: 10.1097/ACO.0b013e32830edafd.
PubMed 18784476
Elias WJ, Durieux ME, Huss D, Frysinger RC. Dexmedetomidine and arousal affect subthalamic neurons. Mov Disord. 2008 Jul 15;23(9):1317-20. doi: 10.1002/mds.22080.
PubMed 18442130

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 18 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Dexmedetomidine vs Propofol on the Recordings of Deep Brain Activity (Local Field Potentials) Measured Through Implanted Stimulators
ClinicalTrials.gov ID: NCT02256319
Acronym / sponsor ID: DEXPROPAR / DEXPROPAR
Conditions: Parkinson's Disease
Keywords: Deep brain stimulation, Dexmedetomidine, Propofol
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
Study start: Sep 2014
Primary completion: Dec 2015 (actual)
Study completion: Dec 2015 (actual)
First posted: 3 Oct 2014 (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.

Detailed description

Comparative clinical trial, non blinded, controlled and sequential, evaluating the effects of propofol and dexmedetomidine in the basal ganglia of PD patients through a DBS electrode.

It is a phase IV clinical trial evaluating the effects of a drug outside the approved.

The study takes part in three phases:

DBS placement under sedation with dexmedetomidine at 0.2 μg/kg/h. This will be called "dexmedetomidine record".
Four days later and with no sedation, a recording will be registered in one of the specialized electrically isolated rooms at the Neurophysiology Department. This will be dubbed "basal recording". The equipment used is also the standard one used for routine postoperative recordings.
5 days after the initial surgery, and following the protocol in place for these procedures, the tunnelization and battery placement will take place. This is done under general anaesthesia. During anaesthetic induction, the patient is exposed to incremental doses of propofol. Different plasmatic concentrations will be targeted using the mathematical model in the target controlled infusion (TCI) pump. These recordings will be called "propofol at a 0.5, 1, 1.5, 2, 2.5 μg/mL".

Study design

Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Dexmedetomidine recording	Experimental	Drug: DexmedetomidineRecording registered through the deep brain stimulation electrodes with dexmedetomidine at 0.2 μg/kg/h.
Propofol recording	Active comparator	Drug: PropofolRecording registered through the deep brain stimulation electrodes with propofol at plasmatic levels of 0.5, 1, 1.5, 2, 2.5 μg/mL.
Basal recording	No intervention	–Recording registered through the deep brain stimulation electrodes with no sedation .

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Capacity to understand, consent and commit for the three phases of the study.
Older than 18 years old.
The patient is scheduled for DBS electrode placement for PD treatment by his neurologist.

Key exclusion criteria (5 listed)

Allergy or hypersensibility to dexmedetomidine or propofol
Cardiac blockade (types 2 and 3) without an implanted pacemaker
Low blood pressure (mean < 60 mmHg) or symptoms of low cardiac output.
Severe cerebrovascular disease.
Pregnancy or nursing mothers.

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
DexmedetomidineAlso: (S)-4-[1-(2,3-Dimethylphenyl)ethyl]-3H-imidazolePatients will receive a loading dose of 1 µg/kg in 10 min before starting the surgery. The maintenance dose will be 0.2-1 µg/kg/h for a Ramsey Sedation Score of 3-4 during the surgery´s preparation. It will be reduced to 0.2 µg/kg/h 15 min before starting the microelectrode recording for a Ramsey Sedation Score of 2. After the placement of the deep brain stimulator we will record the local field potentials activity. In addition, the subscales of rigidity, tremor and bradykinesia of the Unified Parkinson's Disease Rating Scale (UPDRS-III) score will be evaluated. Once the deep brain stimulator recording and neurologic exploration will be over patients will receive a maintenance dose 0.2-1 µg/kg/h until the end of the surgery. It will be stopped to transfer the patient to the ICU.	Drug	Dexmedetomidine recording
PropofolAlso: 2,6-diisopropylphenolThe target doses are 0.5, 1, 1.5, 2 and 2.5 µg/kg. For its administration we will use the TCI (target controlled infusion) system. After programming each dose we will wait until the plasma and brain concentration of propofol are stabilized in this target and then we will record the local field potentials activity through the DBS. In addition, the subscales of rigidity, tremor and bradykinesia of the UPDRS-III score will be evaluated.	Drug	Propofol recording

Primary outcome

Signal power of the local field potentials.
Time frame: 5 minutes for each record
Signal power separated in bandwidth (theta, slow beta, fast beta, gamma, high frequency); absolute and relative. The comparison will be made between the different measurements: dexmedetomidine, basal and propofol.

1 secondary outcome

UPDRS-III score
Time frame: 2 minutes for each score

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 18 Dec 2015.
Background: PubMed 14614167Krack P, Batir A, Van Blercom N, Chabardes S, Fraix V, Ardouin C, Koudsie A, Limousin PD, Benazzouz A, LeBas JF, Benabid AL, Pollak P. Five-year follow-up of bilateral stimulation of the subthalamic nucleus in advanced Parkinson's disease. N Engl J Med. 2003 Nov 13;349(20):1925-34. doi: 10.1056/NEJMoa035275.
Background: PubMed 15918948Hamani C, Richter E, Schwalb JM, Lozano AM. Bilateral subthalamic nucleus stimulation for Parkinson's disease: a systematic review of the clinical literature. Neurosurgery. 2005 Jun;56(6):1313-21; discussion 1321-4. doi: 10.1227/01.neu.0000159714.28232.c4.
Background: PubMed 19556271Poon CC, Irwin MG. Anaesthesia for deep brain stimulation and in patients with implanted neurostimulator devices. Br J Anaesth. 2009 Aug;103(2):152-65. doi: 10.1093/bja/aep179. Epub 2009 Jun 25.
Background: PubMed 22780449Sassi M, Zekaj E, Grotta A, Pollini A, Pellanda A, Borroni M, Pacchetti C, Menghetti C, Porta M, Servello D. Safety in the use of dexmedetomidine (precedex) for deep brain stimulation surgery: our experience in 23 randomized patients. Neuromodulation. 2013 Sep-Oct;16(5):401-6; discussion 406. doi: 10.1111/j.1525-1403.2012.00483.x. Epub 2012 Jul 10.
Background: PubMed 17056959Rozet I, Muangman S, Vavilala MS, Lee LA, Souter MJ, Domino KJ, Slimp JC, Goodkin R, Lam AM. Clinical experience with dexmedetomidine for implantation of deep brain stimulators in Parkinson's disease. Anesth Analg. 2006 Nov;103(5):1224-8. doi: 10.1213/01.ane.0000239331.53085.94.
Background: PubMed 19187268Reck C, Florin E, Wojtecki L, Krause H, Groiss S, Voges J, Maarouf M, Sturm V, Schnitzler A, Timmermann L. Characterisation of tremor-associated local field potentials in the subthalamic nucleus in Parkinson's disease. Eur J Neurosci. 2009 Feb;29(3):599-612. doi: 10.1111/j.1460-9568.2008.06597.x. Epub 2009 Jan 28.
Background: PubMed 21059746Rodriguez-Oroz MC, Lopez-Azcarate J, Garcia-Garcia D, Alegre M, Toledo J, Valencia M, Guridi J, Artieda J, Obeso JA. Involvement of the subthalamic nucleus in impulse control disorders associated with Parkinson's disease. Brain. 2011 Jan;134(Pt 1):36-49. doi: 10.1093/brain/awq301. Epub 2010 Nov 8.
Background: PubMed 18951542Urrestarazu E, Iriarte J, Alegre M, Clavero P, Rodriguez-Oroz MC, Guridi J, Obeso JA, Artieda J. Beta activity in the subthalamic nucleus during sleep in patients with Parkinson's disease. Mov Disord. 2009 Jan 30;24(2):254-60. doi: 10.1002/mds.22351.
Results publication: PubMed 15975946Rodriguez-Oroz MC, Obeso JA, Lang AE, Houeto JL, Pollak P, Rehncrona S, Kulisevsky J, Albanese A, Volkmann J, Hariz MI, Quinn NP, Speelman JD, Guridi J, Zamarbide I, Gironell A, Molet J, Pascual-Sedano B, Pidoux B, Bonnet AM, Agid Y, Xie J, Benabid AL, Lozano AM, Saint-Cyr J, Romito L, Contarino MF, Scerrati M, Fraix V, Van Blercom N. Bilateral deep brain stimulation in Parkinson's disease: a multicentre study with 4 years follow-up. Brain. 2005 Oct;128(Pt 10):2240-9. doi: 10.1093/brain/awh571. Epub 2005 Jun 23.
Results publication: PubMed 21772140Venkatraghavan L, Manninen P. Anesthesia for deep brain stimulation. Curr Opin Anaesthesiol. 2011 Oct;24(5):495-9. doi: 10.1097/ACO.0b013e32834a894c.
Results publication: PubMed 20142347Venkatraghavan L, Luciano M, Manninen P. Review article: anesthetic management of patients undergoing deep brain stimulator insertion. Anesth Analg. 2010 Apr 1;110(4):1138-45. doi: 10.1213/ANE.0b013e3181d2a782. Epub 2010 Feb 8.
Results publication: PubMed 20841416Raz A, Eimerl D, Zaidel A, Bergman H, Israel Z. Propofol decreases neuronal population spiking activity in the subthalamic nucleus of Parkinsonian patients. Anesth Analg. 2010 Nov;111(5):1285-9. doi: 10.1213/ANE.0b013e3181f565f2. Epub 2010 Sep 14.

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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.

Martínez S Antonio, Doctor principal investigator

Staff of the deparment of Anestesiology

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dexmedetomidine and Propofol in people with Parkinson's Disease, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.

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 18 Dec 2015. 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 Spain. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Signal power of the local field potentials. (time frame: 5 minutes for each record). 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 NCT02256319, which also lists 15 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 18 Dec 2015.