PainNCT02006433
Treatment of Pain and Autonomic Dysreflexia in Spinal Cord Injury With Deep Brain Stimulation
A study testing Deep Brain Stimulation in people with Pain and Autonomic Dysreflexia, run by Jonathan Jagid at 2 sites in United States.
Trial summary
The purpose of this research study is to determine if DBS is a feasible, safe and effective therapy for pain and autonomic dysreflexia after spinal cord injury. Read more about this study
- Who is it for?
- Ages 22 to 60 years
- Conditions the study is for
- Pain, Autonomic Dysreflexia
- What is being tested?
- Deep Brain Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2013to Sep 2017
- 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 22 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 22-60 years of age
- Level of injury at or above T12
- Neuropathic pain at or below the level of injury, as determined based on pain in an area with neurological deficit and described as burning, shooting, electric, stinging etc.
- The injury must have occurred at least 1 year prior to entering the study and participants must have experienced chronic pain for a minimum of six months.
- The injury level must be at or above T12, and the disability must have a grade on the American Spinal Injury Association Impairment Scale (AIS) of ASIA-A, ASIA-B, ASIA-C or ASIA-D as determined by a qualified examiners.
- Autonomic dysreflexia can be present, but is not a requirement. This is defined as a rise of systolic pressure by more than 30 mmHg during noxious skin stimulation or when the bladder or bowel is full, or apparently spontaneously over a period of minutes.
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- Pain (neuropathic) of moderate severity or greater is present, when the patient is taking medication, with a score of at least 4 on a numerical rating scale (range of 0 to 10).
- Treatment with at least two of the following drug classes must have failed to give satisfactory pain relief within the last two years: anticonvulsants e.g., pregabalin, gabapentin); antidepressants (e.g., trazodone, amitriptyline); NSAIDS (e.g., ibuprofen). In addition, at least one of the following must have proved ineffective: exercise-based rehabilitation, massage therapy using a variety of methods, acupuncture using pressure, needles, heat, or electrical stimulation on specific points on the body and psychological interventions such as cognitive therapy.
- The subject must be taking pain medication to maintain a stable level of medication from 4 weeks before surgery to 12 weeks after (the primary endpoint), except on the day of surgery.
- Participants on medications for other conditions, such as diabetes, will be considered as candidates for this study. The dose will be monitored throughout the trial. (They will be excluded if the drug is being used to treat epilepsy, Parkinson's diseases, or other brain degenerative diseases.)
- The subject must be willing to comply with the protocol including all scheduled visits.
- Literate at 8th grade level or above.
- Subject must provide a letter of clearance for the DBS surgery from primary care physician
Who cannot join
- Unable to give informed consent
- Prisoner or ward of the state
- Pregnancy
- Prior history of abusing nonprescribed drugs
- Recent (one-year) history of alcohol abuse
- ASIA motor exam unobtainable
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- History of cardiac arrhythmia
- Renal disease, heart disease or uncontrolled hypertension (except due to autonomic dysreflexia), liver disease or hepatic cirrhosis
- Active major medical or psychiatric illness
- Significant post-traumatic encephalopathy from head trauma sustained at SCI
- Languages without local expertise
- Pain is only nociceptive, or due to muscle spasms
- Coagulopathy requiring anticoagulation therapy
- Thrombocytopenia or platelet dysfunction
- Peripheral vascular disease
- Comorbid neurological diseases or disorders, including a history of seizures
- Active systemic infection or concurrent immunosuppressive therapy
- Existing implantable cardiac pacemaker, defibrillator,or neurostimulator
- Requiring short-wave or microwave diathermy treatment
- Inability to cooperate
- Any contraindication to MRI studies (All future MRIs, with the exception of brain MRIs, are excluded.)
- Adverse reaction to stimulation (such as inability to stimulate at analgesic levels without causing clinical hypertension or hypotension) or allergy or hypersensitivity to any materials of the neurostimulation system
- Depression, as defined by a Beck Depression Inventory (BDI-1a) score above 30.
- Subjects with any clinically significant abnormality, not expected on the basis of age (age-related), that is seen in magnetic resonance imaging (MRI).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Miami Hospital
Miami, Florida, 33136
VA Medical Center
Miami, Florida, 33136
About this study
The purpose of this research study is to determine if DBS is a feasible, safe and effective therapy for pain and autonomic dysreflexia after spinal cord injury.
- Conditions
- Pain, Autonomic Dysreflexia
- Being tested
- Deep Brain Stimulation
- Medical subject headings
- Pain, Autonomic Dysreflexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Brain StimulationDevice
Also called The Medtronic Models 3387 and 3389 DBS Leads neurostimulation system for deep brain stimulation.
Local anesthesis, MRI and CT scan of the brain followed by implantation of the stimulation device
| Study group | Role | What they receive |
|---|---|---|
| Deep Brain Stimulation | Experimental | Deep brain stimulation (DBS) for the alleviation of chronic neuropathic pain in patients with spinal cord injury (SCI). The stimulation will be applied bilaterally or unilaterally in the midbrain periaqueductal/periventricular gray region (PAG/PVG).
Extended participation in the study, which will last approximately 2 more years, precisely 104 weeks.The purpose of this extended portion of the study is to obtain long-term follow-up information on safety and efficacy, in subjects that have opted to receive continuing brain stimulation. Investigators label weeks in terms of original enrollment. Thus the surgery occurs in weeks 7 and 8 and the original study finishes in week 52, with the extension lasting from week 53 to week 156. Receives: Device: Deep Brain Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain as measured by Neuropathic Pain Symptom Inventory (NPSI)
Neuropathic Pain Symptom Inventory (NPSI) is a 12 item questionnaire with each question scored form 0-10 with the highest score indicating greater pain
Measured: Baseline, up to 52 weeks
Change in Pain as measured by Multidimensional pain Inventory (MPI-SCI)
Multidimensional pain Inventory (MPI-SCI) is a self-report questionnaire consisting of 50 items, each questioned scored from 0-6, with the higher score being the greatest impact of pain on an individuals daily life.
Measured: Baseline, up to 52 weeks
Change in Pain as measured by the Basic Pain Data Set
The Basic Pain Data set is a 4 question assessing change in pain in the past week using 0-6 scale on each item with the higher score indicating greater pain intensity
Measured: Baseline, up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonathan Jagid
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor-investigator, Jonathan Jagid, University of Miami
- Investigators
- Jonathan R Jagid, M.D., Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02006433
- Sponsor's protocol ID
- 20120429
- Other IDs
- W81XWH-12-1-0559
- Status last verified
- Oct 2020
- First submitted
- 25 Oct 2013
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Pain and Autonomic Dysreflexia in Spinal Cord Injury With Deep Brain Stimulation
- ClinicalTrials.gov ID
- NCT02006433
- Acronym / sponsor ID
- 20120429
- Conditions
- Pain, Autonomic Dysreflexia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Jonathan JagidUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- Dec 2013
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 10 Dec 2013 (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 purpose of this research study is to determine if DBS is a feasible, safe and effective therapy for pain and autonomic dysreflexia after spinal cord injury.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Deep Brain Stimulation | Experimental | Device: Deep Brain StimulationDeep brain stimulation (DBS) for the alleviation of chronic neuropathic pain in patients with spinal cord injury (SCI). The stimulation will be applied bilaterally or unilaterally in the midbrain periaqueductal/periventricular gray region (PAG/PVG). Extended participation in the study, which will last approximately 2 more years, precisely 104 weeks.The purpose of this extended portion of the study is to obtain long-term follow-up information on safety and efficacy, in subjects that have opted to receive continuing brain stimulation. Investigators label weeks in terms of original enrollment. Thus the surgery occurs in weeks 7 and 8 and the original study finishes in week 52, with the extension lasting from week 53 to week 156. |
Who may qualify
- Ages
- 22 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Age 22-60 years of age
- Level of injury at or above T12
- Neuropathic pain at or below the level of injury, as determined based on pain in an area with neurological deficit and described as burning, shooting, electric, stinging etc.
- The injury must have occurred at least 1 year prior to entering the study and participants must have experienced chronic pain for a minimum of six months.
- The injury level must be at or above T12, and the disability must have a grade on the American Spinal Injury Association Impairment Scale (AIS) of ASIA-A, ASIA-B, ASIA-C or ASIA-D as determined by a qualified examiners.
Key exclusion criteria (24 listed)
- Unable to give informed consent
- Prisoner or ward of the state
- Pregnancy
- Prior history of abusing nonprescribed drugs
- Recent (one-year) history of alcohol abuse
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 StimulationAlso: The Medtronic Models 3387 and 3389 DBS Leads neurostimulation system for deep brain stimulation.Local anesthesis, MRI and CT scan of the brain followed by implantation of the stimulation device | Device | Deep Brain Stimulation |
Primary outcome
Change in Pain as measured by Neuropathic Pain Symptom Inventory (NPSI)
Time frame: Baseline, up to 52 weeks
Neuropathic Pain Symptom Inventory (NPSI) is a 12 item questionnaire with each question scored form 0-10 with the highest score indicating greater pain
Change in Pain as measured by Multidimensional pain Inventory (MPI-SCI)
Time frame: Baseline, up to 52 weeks
Multidimensional pain Inventory (MPI-SCI) is a self-report questionnaire consisting of 50 items, each questioned scored from 0-6, with the higher score being the greatest impact of pain on an individuals daily life.
Change in Pain as measured by the Basic Pain Data Set
Time frame: Baseline, up to 52 weeks
The Basic Pain Data set is a 4 question assessing change in pain in the past week using 0-6 scale on each item with the higher score indicating greater pain intensity
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 8 Oct 2020.
- Individual participant dataSharing planned: No
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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.
Jonathan R Jagid, M.D. principal investigator
University of Miami
2 sites 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 in people with Pain and Autonomic Dysreflexia, run by Jonathan Jagid at 2 sites 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 13 inclusion and 24 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 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
Change in Pain as measured by Neuropathic Pain Symptom Inventory (NPSI) (time frame: Baseline, up to 52 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Oct 2020.