Chronic PainDBSNCT01072656

Safety Study of Deep Brain Stimulation to Manage Thalamic Pain Syndrome

A study testing Deep Brain Stimulation for Thalamic Pain Syndrome in people with Chronic Pain, run by Andre Machado at 1 site in United States.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 21 years and older
Conditions the study is for: Chronic Pain
What is being tested?: Deep Brain Stimulation for Thalamic Pain Syndrome
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 10 participants
Where: 1 siteUnited States
Study dates: May 2010to Mar 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Clinical diagnosis of thalamic pain syndrome
with allodynia or dysesthesia
with pinprick anesthesia or hypoesthesia on the affected hemibody (anesthesia dolorosa).
Six months or more of medically refractory severe pain (see below).
Pain disability reported by the pain index >30 points at the time of enrollment.
Average daily pain for the past 30 days reported as >5 on a 0-10 scale

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Failure to respond adequately to at least one antidepressant, one anti-seizure medication and one oral narcotic.
MRI done within one year of the first visit showing a lesion that involves the posterior thalamic region or a lesion in the dorsal or ventral vicinity of the thalamus (i.e. semi oval white matter or brain stem). The lesion will be contralateral to the hemibody affected by chronic pain or will involve cortical-subcortical areas in topography consistent with sensory thalamocortical connections. This will include patients with infarcts in the territory of the middle cerebral artery. A more recent MRI may be required if the patient's condition changed within the previous year.
Capable of understanding and providing informed consent
Age ≥ 21 years
Women of childbearing age must be on regular use of an accepted contraceptive method(s).
Previous surgical procedures: Patients with severe and refractory thalamic pain syndrome may have undergone other interventional or surgical procedures, as an attempt to alleviate the thalamic pain syndrome. Surgical procedure may include blocks, spinal cord stimulation, thalamic DBS, posterior limb of the internal capsule DBS or periaqueductal gray / periventricular gray DBS, cortical stimulation, peripheral ablative procedures or cerebral ablative procedures. In this study, patients with previously implanted cortical stimulation systems, or spinal and peripheral nervous system stimulation systems may be included. However, patients with previous motor cortex stimulation must have had the cortical stimulation system before being considered a candidate for this protocol. Removal of the cortical stimulation system will not be covered under this protocol. Patients with spinal or peripheral neuromodulation system may be included in the research provided that the implanted systems are compatible with the all research protocols (including fMRI) to be performed during the research. Patients with pervious DBS implants will not be considered candidates.

Who cannot join

Not capable of understanding or providing informed consent.
Aphasia severe enough to limit the consent process or communication between the investigators and the patient. Patients with mild or recovering aphasia may be considered candidates at the discretion of the PI.
Coagulopathy. Patients will be excluded unless assessed and cleared by hematology
Inability to stop Coumadin or platelet anti-aggregation therapy for surgery and after surgery. Patients taking these medications will need to discuss the need/risk of continuing these medications with their physicians and the PI or study personnel may contact the treating physician(s) as well to discuss the risks of anticoagulation / antiaggregation therapy discontinuation.
Uncontrolled hypertension.
Malignancy with < 5 years life expectancy.

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Major medical co-morbidities: end stage renal failure, heart failure, severe congestive heart disease, severe respiratory problems, liver failure or other significant medical co morbidities.
Major neurological disorder other than the one that led to the TPS.
MRI (done within one year of the first visit) with abnormalities other than those associated with the neurological disorder causing TPS.
Age < 21 years.
Pregnancy or lack of regular use of contraceptives. Patients who become pregnant after enrollment may be excluded from the study. Patients who become pregnant prior to the surgical implantation of the DBS systems will be excluded from the study.
Previous ablative intracranial surgery for the management of the TPS.
Previously implanted with deep brain stimulation system.
Concurrent enrolment in any other trial / study for TPS.
Implantable hardware not compatible with MRI or with the study.
Patients may be excluded from enrollment due to a condition that, in the judgment of the PI, significantly increases risk or reduces significantly the likelihood of benefit from VC/VS DBS.
Untreated / uncontrolled (severe at the time of enrolment) depression or other psychiatric disorder.
Bipolar disorder, current PTSD, severe personality disorder, active psychosis, Severe OCD.
Psychological co-morbidities that indicates higher risk to the patient and / or higher risk of failure.
Suicide attempt </= 12 months
Communication of a plan for suicide, prior to implant, should the study treatment fail
Imminent suicide risk

Trial locations and contacts

1 site in 1 country.

United States1 site

Cleveland Clinic Foundation
Cleveland, Ohio, 44195

Other trials in United States

About this study

Official title: Deep Brain Stimulation for Thalamic Pain Syndrome

The purpose of this study is to determine the safety and efficacy of Deep Brian Stimulation (DBS) of the ventral capsular/ventral striatal as a treatment for patients with Thalamic Pain Syndrome (TPS). The central hypothesis to be tested in this investigation is that VC/VS stimulation will modulate the affective component of TPS and, consequently, improve pain related disability.

Read the detailed description

This is a pilot clinical study of the therapeutic benefits of ventral capsular/ventral striatal deep brain stimulation (DBS) as a treatment for 10 patients with medically refractory thalamic pain syndrome. Patients to be enrolled under this protocol will have experienced severe pain for more than six months and will be considered medically refractory. Study subjects may have undergone and failed other surgical procedures or interventional procedures. Study subjects will have chronic, medically refractory pain of disabling severity, refractory to treatment attempts with conventional medications. Patients that are enrolled in the study will have bilateral DBS surgery, with implantation of one Medtronic 3391 DBS lead on either side of the brain. These leads will then be connected at first to a single Medtronic PC pulse generator to be implanted in the infraclavicular region on one side. Once the PC pulse generator is depleted, and the patient has completed the blinded phase of the study, the PC pulse generator will be replaced for an RC pulse generator. The RC pulse generator has a battery life of 9 years and is a good option for the open label phase and for continued stimulation after the study is completed. However, the RC is not ideal for the blinded phase because patients may be able to tell if they are receiving active or sham stimulation. For this reason, patients enrolled in this study will receive, initially, the implant with the PC generator. Patients will have at least 6 months of stable chronic pain associated with TPS.

Conditions: Chronic Pain
Being tested: Deep Brain Stimulation for Thalamic Pain Syndrome
Medical subject headings: Chronic Pain

What participants receive

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

Deep Brain Stimulation for Thalamic Pain SyndromeDevice
Patients will be randomized in a 1:1 ratio to one of two groups: the Treatment Group (active stimulation and programmed to the settings found to be optimal during the titration phase) and the Control Group (sham stimulation - IPG is set to ON but the voltage is set to 0V). In order to prevent too many patients from being randomized to ON or to sham early in the study, we will use, for the first 4 patients, randomization blocks of four or six. In this fashion, the first four consecutive patients will have two patients randomized to the Treatment Group and two patients in the Control Group. In the same fashion, the final six patients will have three patients randomized to the treatment group and three patients to the control group.

Study groups in NCT01072656
Study group	Role	What they receive
Treatment group	Active comparator	Active stimulation and programmed to the settings found to be optimal during the titration process. Receives: Device: Deep Brain Stimulation for Thalamic Pain Syndrome
Control group	Sham comparator	IPG is set to ON but the voltage is set to 0V. Receives: Device: Deep Brain Stimulation for Thalamic Pain Syndrome

What is being measured

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

Number of Participants With 50% Improvement in Pain Related Disability (as Assessed by the Pain Disability Index)
Pain Disability Index (PDI) directly measures disability related to the main components of daily life function and has been validated for thalamic pain syndrome. Range is 0 (no disability) to 10 (worst disability). The components are Family/Home Responsibilities, Recreation, Social Activity, Sexual Behavior, Life-support Activity, Occupation, \& Self-care. This is an average score of the 3 month period for each Active and Sham phase.
Measured: Blinded stimulation phase (3 Months)

Secondary outcomes (3)

Number of Participants Who Had 50% Improvement in PDI
A 50% improvement in pain related disability (as assessed by the pain disability index) at the end of the open label phase compared to the pre-implantation baseline. The PDI ranges from 0-10 with 0 equaling no disability and 10 equaling worst disability.
Measured: 24 months post randomization follow up
Number of Participants Who Would Undergo the Procedure Again.
A positive answer from patients receiving active stimulation at the end of the open label phase of the study to the question: 'would you undergo this procedure again if you were to get the same benefits you experienced?'
Measured: End of Open Label Phase (24 months)
Number of Patient Who Had >50% Reduction in VAS.
Patients report reduction in the VAS (Visual Analogue Scale Ranging from 0-10, 0 meaning no pain and 10 meaning worst pain imaginable) at the end of the open label phase (24 months post randomization f/u) compared to the pre-implantation baseline.
Measured: Baseline and 24 months

Timeline

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

May 2010Mar 2016

First posted22 Feb 2010 (estimated)
Study startMay 2010
Primary completionAug 2014
Study completionMar 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Chronic PainStudies 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: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01072656
Sponsor's protocol ID: AGM-001
Other IDs: 1DP2OD006469-01
Acronym: DBS
Status last verified: May 2017
First submitted: 19 Feb 2010
Last updated: 9 Jun 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Gopalakrishnan R, Burgess RC, Lempka SF, Gale JT, Floden DP, Machado AG. Pain anticipatory phenomena in patients with central poststroke pain: a magnetoencephalography study. J Neurophysiol. 2016 Sep 1;116(3):1387-95. doi: 10.1152/jn.00215.2016. Epub 2016 Jun 29.
PubMed 27358316
Gopalakrishnan R, Burgess RC, Plow EB, Floden DP, Machado AG. Early event related fields during visually evoked pain anticipation. Clin Neurophysiol. 2016 Mar;127(3):1855-63. doi: 10.1016/j.clinph.2015.11.019. Epub 2015 Dec 5.
PubMed 26733321
Plow EB, Malone DA Jr, Machado A. Deep brain stimulation of the ventral striatum/anterior limb of the internal capsule in thalamic pain syndrome: study protocol for a pilot randomized controlled trial. Trials. 2013 Jul 31;14:241. doi: 10.1186/1745-6215-14-241.
PubMed 23902631

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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 9 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Deep Brain Stimulation for Thalamic Pain Syndrome
ClinicalTrials.gov ID: NCT01072656
Acronym / sponsor ID: DBS / AGM-001
Conditions: Chronic Pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: Andre MachadoUniversity, hospital or other
Collaborators: National Institutes of Health (NIH)
Study start: May 2010
Primary completion: Aug 2014 (actual)
Study completion: Mar 2016 (actual)
First posted: 22 Feb 2010 (estimated)
Results: Posted 30 Aug 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Treatment group	Active comparator	Device: Deep Brain Stimulation for Thalamic Pain SyndromeActive stimulation and programmed to the settings found to be optimal during the titration process.
Control group	Sham comparator	Device: Deep Brain Stimulation for Thalamic Pain SyndromeIPG is set to ON but the voltage is set to 0V.

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

Clinical diagnosis of thalamic pain syndrome
with allodynia or dysesthesia
with pinprick anesthesia or hypoesthesia on the affected hemibody (anesthesia dolorosa).
Six months or more of medically refractory severe pain (see below).
Pain disability reported by the pain index >30 points at the time of enrollment.

Key exclusion criteria (22 listed)

Not capable of understanding or providing informed consent.
Aphasia severe enough to limit the consent process or communication between the investigators and the patient. Patients with mild or recovering aphasia may be considered candidates at the discretion of the PI.
Coagulopathy. Patients will be excluded unless assessed and cleared by hematology
Inability to stop Coumadin or platelet anti-aggregation therapy for surgery and after surgery. Patients taking these medications will need to discuss the need/risk of continuing these medications with their physicians and the PI or study personnel may contact the treating physician(s) as well to discuss the risks of anticoagulation / antiaggregation therapy discontinuation.
Uncontrolled hypertension.

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
Deep Brain Stimulation for Thalamic Pain SyndromePatients will be randomized in a 1:1 ratio to one of two groups: the Treatment Group (active stimulation and programmed to the settings found to be optimal during the titration phase) and the Control Group (sham stimulation - IPG is set to ON but the voltage is set to 0V). In order to prevent too many patients from being randomized to ON or to sham early in the study, we will use, for the first 4 patients, randomization blocks of four or six. In this fashion, the first four consecutive patients will have two patients randomized to the Treatment Group and two patients in the Control Group. In the same fashion, the final six patients will have three patients randomized to the treatment group and three patients to the control group.	Device	Control group, Treatment group

Primary outcome

Number of Participants With 50% Improvement in Pain Related Disability (as Assessed by the Pain Disability Index)
Time frame: Blinded stimulation phase (3 Months)
Pain Disability Index (PDI) directly measures disability related to the main components of daily life function and has been validated for thalamic pain syndrome. Range is 0 (no disability) to 10 (worst disability). The components are Family/Home Responsibilities, Recreation, Social Activity, Sexual Behavior, Life-support Activity, Occupation, \& Self-care. This is an average score of the 3 month period for each Active and Sham phase.

3 secondary outcomes

Number of Participants Who Had 50% Improvement in PDI
Time frame: 24 months post randomization follow up
Number of Participants Who Would Undergo the Procedure Again.
Time frame: End of Open Label Phase (24 months)
Number of Patient Who Had >50% Reduction in VAS.
Time frame: Baseline and 24 months

Results and safety

Results posted to the registry on 30 Aug 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active First	5	5
Sham First	4	4

Primary outcome: Number of Participants With 50% Improvement in Pain Related Disability (as Assessed by the Pain Disability Index)

Time frame: Blinded stimulation phase (3 Months). Number. Unit: participants

Measure	Active Stimulation n = 9	Sham Stimulation n = 9
Value	2	0

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active Stimulation (Phase V)	3 of 9 (33.3%)	9 of 9 (100%)	Not reported
Sham Stimulation (Phase V)	2 of 9 (22.2%)	9 of 9 (100%)	Not reported
Phase I-IV	0 of 9 (0%)	9 of 9 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 27358316Gopalakrishnan R, Burgess RC, Lempka SF, Gale JT, Floden DP, Machado AG. Pain anticipatory phenomena in patients with central poststroke pain: a magnetoencephalography study. J Neurophysiol. 2016 Sep 1;116(3):1387-95. doi: 10.1152/jn.00215.2016. Epub 2016 Jun 29.
Background: PubMed 26733321Gopalakrishnan R, Burgess RC, Plow EB, Floden DP, Machado AG. Early event related fields during visually evoked pain anticipation. Clin Neurophysiol. 2016 Mar;127(3):1855-63. doi: 10.1016/j.clinph.2015.11.019. Epub 2015 Dec 5.
Derived from this study: PubMed 23902631Plow EB, Malone DA Jr, Machado A. Deep brain stimulation of the ventral striatum/anterior limb of the internal capsule in thalamic pain syndrome: study protocol for a pilot randomized controlled trial. Trials. 2013 Jul 31;14:241. doi: 10.1186/1745-6215-14-241.

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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.

Andre G Machado, MD principal investigator

The Cleveland Clinic

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

Questions about this trial

What is this clinical trial studying?

A study testing Deep Brain Stimulation for Thalamic Pain Syndrome in people with Chronic Pain, run by Andre Machado at 1 site in United States.

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 12 inclusion and 22 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 9 Jun 2017. 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 United States. 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 30 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With 50% Improvement in Pain Related Disability (as Assessed by the Pain Disability Index) (time frame: Blinded stimulation phase (3 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 NCT01072656, which also lists 3 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 9 Jun 2017.