Severe Neuropathic Pain Due to Radiculopathy or Radicular InjuryNCT03111277
MR Guided Focused Ultrasound for Treatment of Neuropathic Pain
A study testing Experimental: ExAblate Transcranial treatment in people with Severe Neuropathic Pain Due to Radiculopathy or Radicular Injury and Spinal Cord Injuries, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
Neuropathic pain is often a result of direct diseases of peripheral or central nervous system with an estimated prevalence of 8% of adults and this pain is associated with significant consequences because of longer symptom duration and severity than many of the other pain syndromes. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Severe Neuropathic Pain Due to Radiculopathy or Radicular Injury, Spinal Cord Injuries, Phantom Limb Pain
- What is being tested?
- Experimental: ExAblate Transcranial treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2017to 9 Oct 2022
- 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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- These include patients with:
- Severe uncontrolled neuropathic pain due to radiculopathy or radicular injury
- Spinal Cord Injury
- Phantom Limb Pain
- Patients that have had prior motor cortex stimulation or spinal cord stimulators will be eligible provided that the hardware has been removed at least six months ago. Detailed inclusion and exclusion criteria for the study are listed below:
- Age greater than 21 and less than 75 years
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- Subjects who are able and willing to give consent and able to attend all study visits,
- Documented Neuropathic pain for more than 6 months duration, confirmed from clinical history and examination by a pain specialist or neurologist
- Failure to respond to any of the usual therapeutic regimens considered to be standard of care for neuropathic pain. The patient should have failed a trial of at least three pain medications, including at least one opioid agent
- Patients with radiculopathy or radicular injury or phantom limb pain should have failed one additional pain intervention such as nerve block, epidural steroid injection, motor cortex or spinal cord stimulator
- Patients with Spinal cord injury, in addition to having failed a trial of three pain medications, should have failed one additional intervention such as Botox injection or intra-thecal baclofen.
- Subjects should have been on stable dose of analgesic agents for at least a period of 4 weeks
- Clinical symptoms consistent with persistent, intractable pain that has remained at average NRS score >5 for 30 days, significant pain related disability (Pain Disability Index (PDI) score >30) or severe allodynia.
- Central lateral thalamotomy is feasible based on evaluation of imaging studies
- Patient able to communicate sensations during the ExAblate TcMRgFUS treatment
- Two members of the medical team have agreed upon inclusion and exclusion criteria.
Who cannot join
- Patient with contra-indications to MRI such as severe claustrophobia and metallic implants incompatible with MRI.
- Severe psychiatric disorder such as uncontrolled depression, bipolar disorder, prior attempt at suicide or suicide ideation in preceding 12 months
- Life expectancy less than 12 months
- Anticoagulant or antiplatelet medications as well as underlying coagulopathy
- Prior or currently implanted thalamic DBS
- Pregnant ladies or women of childbearing age who are sexually active and not using contraception
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- Inability to provide informed consent, for example due to underlying cognitive impairment or aphasia
- Presence of intracranial mass or an acute intracranial abnormality
- Subjects with unstable cardiac status such as Unstable angina pectoris, documented myocardial infarction within 6 months of protocol entry and ejection fraction less than 40
- Subjects exhibiting any behavior(s) consistent with ethanol or substance abuse as defined by the criteria outlined in the DSM-IV as manifested by one (or more) of the following occurring within a 12 month period:
- Recurrent substance use resulting in a failure to fulfill major role obligations at work, school, or home (such as repeated absences or poor work performance related to substance use; substance-related absences, suspensions, or expulsions from school; or neglect of children or household).
- Recurrent substance use in situations in which it is physically hazardous (such as driving an automobile or operating a machine when impaired by substance use)
- Recurrent substance-related legal problems (such as arrests for substance related disorderly conduct)
- Continued substance use despite having persistent or recurrent social or interpersonal problems caused or exacerbated by the effects of the substance (for example, arguments with spouse about consequences of intoxication and physical fights).
- Severe hypertension (diastolic BP > 100 on medication or persistently elevated SBP>140 mmHg despite antihypertensive medications)
- History of immunocompromise including those who are HIV positive.
- History of CNS disease (this includes but not limited to intracranial hemorrhage, Traumatic brain injury or thalamic stroke, seizures within the past year, brain tumors, multiple CVA or CVA within 6 months)
- Subjects with life-threatening systemic disease that include and not limited to the following will be excluded from the study participation: HIV, Liver Failure, blood dyscrasias, etc.
- Individuals who are not able or willing to tolerate the required prolonged stationary supine position during treatment (can be up to 4 hrs of total table time.)
- Are participating or have participated in another clinical trial in the last 30 days
- Patients receiving a Morphine equivalent dose of greater than 90 mg per day
- Subjects who have non-neuropathic pain as the major component of their pain presentation will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland School of Medicine and University of Maryland Medical Systems
Baltimore, Maryland, 21201
About this study
Official title: Phase 1 Clinical Trial for MR Guided Focused Ultrasound (FUS) Thalamotomy of Central Lateral Thalamic Nucleus for the Treatment of Neuropathic Pain
Neuropathic pain is often a result of direct diseases of peripheral or central nervous system with an estimated prevalence of 8% of adults and this pain is associated with significant consequences because of longer symptom duration and severity than many of the other pain syndromes. Functional brain imaging has revealed that many regions of the brain are engaged by painful events, but specific areas such as the thalamus have been markedly implicated.
The purpose of this study is to determine the feasibility and safety of MRI-guided focused ultrasound treatment using the ExAblate Transcranial System in patients suffering from Neuropathic pain. This treatment modality offers non-invasive precise treatment potential for these patients.
Read the detailed description
The primary purpose of this study is to assess the safety of MRI-guided focused ultrasound (MRgFUS) in patients with chronic neuropathic pain whose medicines are not working well. The device that will be used to create and send ultrasound waves through the skull is called the ExAblate Transcranial system. The ultrasounds waves will precisely target a small part of the brain known as the thalamus. Chronic neuropathic pain is a common type of disabling pain that affects people.
Usually, people with chronic neuropathic pain are treated with medicines to control the pain. However, these medications may not provide adequate relief of the pain or may be associated with undesirable side effects. This study intends to investigate the use of a new technology The ExAblate transcranial system for treating patients that are not responding to medications and continue to have disabling pain.
The ExAblate Transcranial system will be used to destroy a small cluster of cells that may be causing the study participant's pain . The ExAblate uses ultrasound to heat a small spot in the brain. The process of ablation is similar to a magnifying glass that uses light to heat a small spot on a piece of paper. Ultrasound passes through the skin and skull and into the brain to focus on a spot the study investigator wants to treat.Once the spot is destroyed, it cannot grow back.
- Conditions
- Severe Neuropathic Pain Due to Radiculopathy or Radicular Injury, Spinal Cord Injuries, Phantom Limb Pain
- Being tested
- Experimental: ExAblate Transcranial treatment
- Keywords
- neuropathic pain
- Medical subject headings
- Spinal Cord Injuries, Phantom Limb, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: ExAblate Transcranial treatmentDevice
Also called The ExAblate® MR guided focused ultrasound system
Patients' head will be placed in a device to hold it still for the treatment. Patients will lie headfirst on the ExAblate table. The ExAblate Transcranial helmet will be placed on their head. A device will be placed over their head to hold it and the helmet still. The investigators will measure the study participant's heart, blood pressure, temperature, and breathing rate before the treatment begins. MRI scans will be taken to make sure the ultrasound waves will be aimed exactly within the target. The space between the rubber diaphragm and the helmet will be filled with water. The water will be chilled to avoid heating of the scalp and skull during the ultrasound treatment. A series of MR images will be taken to identify the target area, and plan the study treatment. The study investigators will decide on the area of participant's brain that will be treated. The ExAblate Transcranial system will compute a plan to cover the treatment area.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: ExAblate Transcranial treatment | Experimental | The ExAblate Transcranial system will be used to destroy a small cluster of cells that may be causing the study participant's pain . The ExAblate uses ultrasound to heat a small spot in the brain. Ultrasound passes through the skin and skull and into the brain to focus on a spot the study investigator wants to treat. Receives: Device: Experimental: ExAblate Transcranial treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment related adverse events
Procedure related or device related adverse events will be reported, from the treatment day through the 12-month follow-up period.
Measured: All events will be reported upto 12 months from treatment
Secondary outcomes (2)
Change in pain measurements using pain numeric rating scale
Reduction at 12 months in maximum or average pain scores as measured on Pain numeric rating scale (NRS) by 40% or more without increase in medication consumption by more than 25%.
Measured: 12 months
Change in pain related disability
Reduction in Pain related disability by greater than or equal to 30% using pain interference scale on the Brief pain inventory (BPI) at 12-month follow-up
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start15 Sep 2017
- Primary completion9 Oct 2022
- Study completion9 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Severe Neuropathic Pain Due to Radiculopathy or Radicular InjuryStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Focused Ultrasound Foundation, InSightec
- Responsible party
- Principal investigator, Dheeraj Gandhi, University of Maryland, Baltimore
- Investigators
- Dheeraj Gandhi, Principal investigator, University of Maryland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03111277
- Sponsor's protocol ID
- HP-00068223
- Status last verified
- Oct 2022
- First submitted
- 27 Mar 2017
- Last updated
- 12 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Publications
Ahmed AK, Zhuo J, Gullapalli RP, Jiang L, Keaser ML, Greenspan JD, Chen C, Miller TR, Melhem ER, Sansur CA, Eisenberg HM, Gandhi D. Focused Ultrasound Central Lateral Thalamotomy for the Treatment of Refractory Neuropathic Pain: Phase I Trial. Neurosurgery. 2024 Apr 1;94(4):690-699. doi: 10.1227/neu.0000000000002752. Epub 2023 Nov 10.
PubMed 37947407
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Clinical Trial for MR Guided Focused Ultrasound (FUS) Thalamotomy of Central Lateral Thalamic Nucleus for the Treatment of Neuropathic Pain
- ClinicalTrials.gov ID
- NCT03111277
- Acronym / sponsor ID
- HP-00068223
- Conditions
- Severe Neuropathic Pain Due to Radiculopathy or Radicular Injury, Spinal Cord Injuries, Phantom Limb Pain
- Keywords
- neuropathic pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Focused Ultrasound Foundation, InSightec
- Study start
- 15 Sep 2017 (actual)
- Primary completion
- 9 Oct 2022 (actual)
- Study completion
- 9 Oct 2022 (actual)
- First posted
- 12 Apr 2017 (actual)
- 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.
Neuropathic pain is often a result of direct diseases of peripheral or central nervous system with an estimated prevalence of 8% of adults and this pain is associated with significant consequences because of longer symptom duration and severity than many of the other pain syndromes. Functional brain imaging has revealed that many regions of the brain are engaged by painful events, but specific areas such as the thalamus have been markedly implicated.
The purpose of this study is to determine the feasibility and safety of MRI-guided focused ultrasound treatment using the ExAblate Transcranial System in patients suffering from Neuropathic pain. This treatment modality offers non-invasive precise treatment potential for these patients.
Detailed description
The primary purpose of this study is to assess the safety of MRI-guided focused ultrasound (MRgFUS) in patients with chronic neuropathic pain whose medicines are not working well. The device that will be used to create and send ultrasound waves through the skull is called the ExAblate Transcranial system. The ultrasounds waves will precisely target a small part of the brain known as the thalamus. Chronic neuropathic pain is a common type of disabling pain that affects people.
Usually, people with chronic neuropathic pain are treated with medicines to control the pain. However, these medications may not provide adequate relief of the pain or may be associated with undesirable side effects. This study intends to investigate the use of a new technology The ExAblate transcranial system for treating patients that are not responding to medications and continue to have disabling pain.
The ExAblate Transcranial system will be used to destroy a small cluster of cells that may be causing the study participant's pain . The ExAblate uses ultrasound to heat a small spot in the brain. The process of ablation is similar to a magnifying glass that uses light to heat a small spot on a piece of paper. Ultrasound passes through the skin and skull and into the brain to focus on a spot the study investigator wants to treat.Once the spot is destroyed, it cannot grow back.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: ExAblate Transcranial treatment | Experimental | Device: Experimental: ExAblate Transcranial treatmentThe ExAblate Transcranial system will be used to destroy a small cluster of cells that may be causing the study participant's pain . The ExAblate uses ultrasound to heat a small spot in the brain. Ultrasound passes through the skin and skull and into the brain to focus on a spot the study investigator wants to treat. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- These include patients with:
- Patients that have had prior motor cortex stimulation or spinal cord stimulators will be eligible provided that the hardware has been removed at least six months ago. Detailed inclusion and exclusion criteria for the study are listed below:
- Age greater than 21 and less than 75 years
- Subjects who are able and willing to give consent and able to attend all study visits,
- Documented Neuropathic pain for more than 6 months duration, confirmed from clinical history and examination by a pain specialist or neurologist
Key exclusion criteria (22 listed)
- Patient with contra-indications to MRI such as severe claustrophobia and metallic implants incompatible with MRI.
- Severe psychiatric disorder such as uncontrolled depression, bipolar disorder, prior attempt at suicide or suicide ideation in preceding 12 months
- Life expectancy less than 12 months
- Anticoagulant or antiplatelet medications as well as underlying coagulopathy
- Prior or currently implanted thalamic DBS
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 |
|---|---|---|
| Experimental: ExAblate Transcranial treatmentAlso: The ExAblate® MR guided focused ultrasound systemPatients' head will be placed in a device to hold it still for the treatment. Patients will lie headfirst on the ExAblate table. The ExAblate Transcranial helmet will be placed on their head. A device will be placed over their head to hold it and the helmet still. The investigators will measure the study participant's heart, blood pressure, temperature, and breathing rate before the treatment begins. MRI scans will be taken to make sure the ultrasound waves will be aimed exactly within the target. The space between the rubber diaphragm and the helmet will be filled with water. The water will be chilled to avoid heating of the scalp and skull during the ultrasound treatment. A series of MR images will be taken to identify the target area, and plan the study treatment. The study investigators will decide on the area of participant's brain that will be treated. The ExAblate Transcranial system will compute a plan to cover the treatment area. | Device | Experimental: ExAblate Transcranial treatment |
Primary outcome
Incidence of Treatment related adverse events
Time frame: All events will be reported upto 12 months from treatment
Procedure related or device related adverse events will be reported, from the treatment day through the 12-month follow-up period.
2 secondary outcomes
Change in pain measurements using pain numeric rating scale
Time frame: 12 months
Change in pain related disability
Time frame: 12 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 12 Oct 2022.
- Derived from this study: PubMed 37947407Ahmed AK, Zhuo J, Gullapalli RP, Jiang L, Keaser ML, Greenspan JD, Chen C, Miller TR, Melhem ER, Sansur CA, Eisenberg HM, Gandhi D. Focused Ultrasound Central Lateral Thalamotomy for the Treatment of Refractory Neuropathic Pain: Phase I Trial. Neurosurgery. 2024 Apr 1;94(4):690-699. doi: 10.1227/neu.0000000000002752. Epub 2023 Nov 10.
- Individual participant dataSharing planned: Yes
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.
Dheeraj Gandhi principal investigator
University of Maryland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: ExAblate Transcranial treatment in people with Severe Neuropathic Pain Due to Radiculopathy or Radicular Injury and Spinal Cord Injuries, run by University of Maryland, Baltimore 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 16 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 12 Oct 2022. 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. 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?
Incidence of Treatment related adverse events (time frame: All events will be reported upto 12 months from treatment). 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 NCT03111277, which also lists 1 linked publication.
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 12 Oct 2022.