Pain, ChronicNCT03380104
Intradural Percutaneous Stimulation
A study testing Intradural Spinal Cord Stimulation and Administration of Questionnaires in people with Pain, Chronic, run by Matthew Howard at 1 site in United States.
Trial summary
The purpose of the study is to test the effects of intradural, spinal cord stimulation using a device placed in the same manner as a lumbar drain performed during a standard epidural spinal cord stimulation (SCS) trial routinely performed prior permanent lead and stimulation device implantation. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pain, Chronic
- What is being tested?
- Intradural Spinal Cord Stimulation and Administration of Questionnaires
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2020to 1 Jun 2020
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with neuropathic pain and concordant neurological findings previously consented for an epidural spinal cord stimulator trial
- Patients greater than 18 years of agree
- Must have one of the following:
- Diagnosed with medically refractory chronic neuropathic pain, post laminectomy pain syndrome, or failed back surgery syndrome and planning to undergo a spinal cord stimulation trial
- Been deemed refractory to all other treatments and would otherwise receive an intrathecal catheter/pump for chronic narcotic administration
- Disease duration of at least 6 months with no lasting success with standard therapies or medications with exception of spinal cord stimulation
Show all 12Show fewer
- Mean pain intensity of a least 5 (or greater) measured on a visual analogue scale from 0 (no pain) to 10 (severe pain)
- MRI or CT Myelogram of the lumbar and thoracic spine (within 12 months prior to screening)
- No compressive spinal pathology or intradural implants (eg., syrinx shunt tubes)
- Psychological screening has been completed and the patient has been cleared by a psychologist or psychiatrist as a suitable SCS candidate
- Female patients of childbearing potential must have a negative serum pregnancy test
- Patients agree to comply with the study protocol and have reviewed and given written informed consent
Who cannot join
- Patients who are unable or unwilling to provide feedback regarding the response
- Subject has an existing intrathecal drug pump
- Pain is attributed to: vascular disorder; musculoskeletal disorder; substance abuse or withdrawal; infection; disorder of homeostasis
- Subject is currently enrolled in another trial
- History of coagulation disorders or patients on chronic anticoagulant or antiplatelet therapy that is not able to be safely held for 14 days
- History of thoracic trauma or spinal surgery extending into the thoracic spine
Show all 19Show fewer
- History of arachnoiditis or intradural spinal surgery that would limit catheter insertion to the target site
- Current clinically significant or disabling chronic pain problem or condition that is likely to confound evaluation of the study endpoints (i.e. chronic migraine, significant arthritis of the hip associated with primary groin pain complaint)
- Radiographic evidence of frank spinal instability (gross mobile spondylolisthesis or abnormal subluxation requiring fusion, calcific arachnoiditis, or severe thoracic or lumbar stenosis
- Subject has a condition that requires diathermy or repeated MRIs
- New medication for pain initiated within 8 weeks prior to initial baseline research evaluation
- Life expectancy less than 3 months
- Systemic infection or local infection of the spine or skin in the anticipated region of catheter insertion.
- Immune deficiency or history of post surgical infection
- Female candidates of childbearing potential who are pregnant (confirmed with a positive serum pregnancy test), not using adequate contraception as determined by the investigator, or nursing (lactating) a child
- Untreated or active psychiatric condition
- Complex regional pain syndrome or other condition that could limit testing or aggravate an ongoing medical condition
- Unresolved issues of secondary gain (i.e. litigation)
- The investigator deems that the subject is not suitable for the study even if they meet all other inclusive/exclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
About this study
Official title: Intradural Percutaneous Stimulation - Inducing Physiological Responses.
The purpose of the study is to test the effects of intradural, spinal cord stimulation using a device placed in the same manner as a lumbar drain performed during a standard epidural spinal cord stimulation (SCS) trial routinely performed prior permanent lead and stimulation device implantation.
Read the detailed description
In this pilot study the investigators will test an ability of intradural electrical stimulation in humans to elicit physiological responses (paresthesia or tingling sensation) and decrease pain when placed in the region of the thoracic spinal cord in a controlled manner. This subject population is comprised of patients that had previously failed various conservative pain management treatment plans and are deemed candidates for treatment of pain by spinal cord stimulation. The investigators will use commercially available device to deliver an intradural electrical stimulation to the spinal cord. This device is FDA approved for intracranial electrophysiological monitoring and delivery of electrical stimulation of the subsurface level of the brain.
As a part of the study, the subject will be offered to complete the following questionnaires to assess quality of life and global function. These questionnaires will be completed prior the procedure and at specified time periods following the research intervention. The experimental portion of the procedure will follow the standard epidural spinal cord stimulator testing. Under fluoroscopic guidance, using a paramedian approach and shallow entry angle, the device will be placed percutaneously at the lumbar spine at L2-3 or L3-4 level into the intrathecal cerebrospinal fluid (CSF) space and advanced to the T8-10 disc space. The stimulation catheter will run through a standardized experimental algorithm further described in greater details. The initial stimulation will last approximately 30 minutes and involve testing for paresthesias (tingling) and measurement of the threshold signal strength for onset of this sensation at 60 hertz (Hz) and 10000 Hz frequences. During this portion the subject will be asked to describe the sensations and rate his or her pain on a 0 to 10 scale. Following this initial stimulation, the frequency will be changed to 10 kilohertz (KHz) to run over the period of 4 hours. The investigators will continue evaluating the effects of stimulation using visual analogue scores during this period of time.
- Conditions
- Pain, Chronic
- Being tested
- Intradural Spinal Cord Stimulation, Administration of Questionnaires
- Keywords
- Percutaneous Electrical Nerve Stimulation
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intradural Spinal Cord StimulationDevice
The device will be placed percutaneously at the lumbar spine at L2-3 or L3-4 level into the intrathecal CSF space and advanced to the T8-10 disc space. After positioning of the intrathecal lead, the stimulation catheter will be run through a standardized experimental algorithm consisting on various frequencies.
Administration of QuestionnairesBehavioural
Subjects will be administered questionnaires to evaluate pain, quality of life, and global function prior the study, at 1 hour after the completion of the study, and at 4 day follow-up appointment.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Intradural Spinal Cord Stimulation; Administration of Questionnaires Receives: Device: Intradural Spinal Cord Stimulation; Behavioral: Administration of Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establishment of paresthesia threshold
Observe and record how various stimulation measures induce paresthesias and record this paresthesia threshold. This will be measured by having the patient state when they feel paresthesias as the stimulation amplitude is increased. This will be recorded as a raw number.
Measured: 30 minutes
Establishment of motor threshold
Observe and record how various stimulation measures induce motor activity and record this motor threshold. This will be measured by having the patient state when they feel motor movement as the stimulation amplitude is increased. This will be recorded as a raw number.
Measured: 30 minutes
Acute Adverse Pain Responses using short-form McGill Pain Questionnaire
Demonstrate that intradural stimulation does not induce adverse painful responses during acute stimulation. Participants will be administered the short-form McGill Pain Questionnaire prior to start of testing and one hour following testing has concluded. The McGill Pain Questionnaire has a range of scores from zero (min) to 45(max) with lower numbers being better.
Measured: 5 hours
Acute Adverse Pain Responses using long form Brief pain inventory (BPI)
Demonstrate that intradural stimulation does not induce adverse painful responses during acute stimulation. Participants will be administered the long form BPI prior to start of testing and one hour following testing has concluded. The brief pain index creates a severity and interference score that ranges from zero (min) and 10 (max) with lower numbers being better.
Measured: 5 hours
Secondary outcomes (2)
Difference in Stimulation Intensity to induce paresthesias
Record the threshold difference in stimulation intensity between epidural and intrathecal stimulation. This will take the data collected from the patient's clinical epidural trial (paresthesia threshold) and compared to the patient's intradural threshold testing.
Measured: 90 minutes
Unexpected/Chronic effects of stimulation
Record unexpected or unanticipated effects of stimulation that may limit its utility or conceivably provide a new avenue for neuromodulation not achievable with epidural stimulation. Participants will be contacted via telephone interviewed to screen for any unexpected outcomes.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2017
- Study start1 Jun 2020 (estimated)
- Primary completion1 Jun 2020 (estimated)
- Study completion1 Jun 2020 (estimated)
Why it stopped: Unable to obtain FDA IDE approval. Currently working on additional preclinical testing.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Pain, ChronicStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All subjects enrolled in this study will undergo Intradural Spinal Cord Stimulation.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Matthew Howard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Matthew Howard, University of Iowa
- Investigators
- Matthew A Howard, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03380104
- Sponsor's protocol ID
- 201708754
- Status last verified
- May 2021
- First submitted
- 24 Oct 2017
- Last updated
- 11 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Charghi R, Chan SY, Kardash KJ, Finlayson RJ, Tran DQ. Electrical stimulation of the epidural space using a catheter with a removable stylet. Reg Anesth Pain Med. 2007 Mar-Apr;32(2):152-6. doi: 10.1016/j.rapm.2006.10.006.
PubMed 17350527Crews JC, Chan VWS. Perioperative management of patients and equipment selection for neural blockade. In: Cousins MJ, Horlocker TT, Bridenbaugh PO, Carr DB, Eds., Neural Blockade in Clinical Anesthesia and Pain Medicine (Wolters Kluwer, Philadelphia, 2009), Chap. 8, 160-180. ISBN-13: 978-0-7817-7388-1
Flouty O, Oya H, Kawasaki H, Wilson S, Reddy CG, Jeffery ND, Brennan TJ, Gibson-Corley KN, Utz M, Gillies GT, Howard MA 3rd. A new device concept for directly modulating spinal cord pathways: initial in vivo experimental results. Physiol Meas. 2012 Dec;33(12):2003-15. doi: 10.1088/0967-3334/33/12/2003. Epub 2012 Nov 15.
PubMed 23151433Gibson-Corley KN, Flouty O, Oya H, Gillies GT, Howard MA. Postsurgical pathologies associated with intradural electrical stimulation in the central nervous system: design implications for a new clinical device. Biomed Res Int. 2014;2014:989175. doi: 10.1155/2014/989175. Epub 2014 Apr 1.
PubMed 24800260Howell B, Lad SP, Grill WM. Evaluation of intradural stimulation efficiency and selectivity in a computational model of spinal cord stimulation. PLoS One. 2014 Dec 23;9(12):e114938. doi: 10.1371/journal.pone.0114938. eCollection 2014.
PubMed 25536035Lena P, Martin R. Subdural placement of an epidural catheter detected by nerve stimulation. Can J Anaesth. 2005 Jun-Jul;52(6):618-21. doi: 10.1007/BF03015772.
PubMed 15983148Pope JE, Stanton-Hicks M. Accidental subdural spinal cord stimulator lead placement and stimulation. Neuromodulation. 2011 Jan;14(1):30-2; discussion 33. doi: 10.1111/j.1525-1403.2010.00299.x. Epub 2010 Oct 7.
PubMed 21992159Reddy CG, Dalm BD, Flouty OE, Gillies GT, Howard MA 3rd, Brennan TJ. Comparison of Conventional and Kilohertz Frequency Epidural Stimulation in Patients Undergoing Trialing for Spinal Cord Stimulation: Clinical Considerations. World Neurosurg. 2016 Apr;88:586-591. doi: 10.1016/j.wneu.2015.10.088. Epub 2015 Nov 14.
PubMed 26585728Sharpe AN, Jackson A. Upper-limb muscle responses to epidural, subdural and intraspinal stimulation of the cervical spinal cord. J Neural Eng. 2014 Feb;11(1):016005. doi: 10.1088/1741-2560/11/1/016005.
PubMed 24654267Toma AK, Papadopoulos MC, Stapleton S, Kitchen ND, Watkins LD. Systematic review of the outcome of shunt surgery in idiopathic normal-pressure hydrocephalus. Acta Neurochir (Wien). 2013 Oct;155(10):1977-80. doi: 10.1007/s00701-013-1835-5. Epub 2013 Aug 23.
PubMed 23975646Tsui BC, Gupta S, Finucane B. Detection of subarachnoid and intravascular epidural catheter placement. Can J Anaesth. 1999 Jul;46(7):675-8. doi: 10.1007/BF03013957.
PubMed 10442964Williams MA, Malm J. Diagnosis and Treatment of Idiopathic Normal Pressure Hydrocephalus. Continuum (Minneap Minn). 2016 Apr;22(2 Dementia):579-99. doi: 10.1212/CON.0000000000000305.
PubMed 27042909
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intradural Percutaneous Stimulation - Inducing Physiological Responses.
- ClinicalTrials.gov ID
- NCT03380104
- Acronym / sponsor ID
- 201708754
- Conditions
- Pain, Chronic
- Keywords
- Percutaneous Electrical Nerve Stimulation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to obtain FDA IDE approval. Currently working on additional preclinical testing.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Matthew HowardUniversity, hospital or other
- Study start
- 1 Jun 2020 (estimated)
- Primary completion
- 1 Jun 2020 (estimated)
- Study completion
- 1 Jun 2020 (estimated)
- First posted
- 20 Dec 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.
The purpose of the study is to test the effects of intradural, spinal cord stimulation using a device placed in the same manner as a lumbar drain performed during a standard epidural spinal cord stimulation (SCS) trial routinely performed prior permanent lead and stimulation device implantation.
Detailed description
In this pilot study the investigators will test an ability of intradural electrical stimulation in humans to elicit physiological responses (paresthesia or tingling sensation) and decrease pain when placed in the region of the thoracic spinal cord in a controlled manner. This subject population is comprised of patients that had previously failed various conservative pain management treatment plans and are deemed candidates for treatment of pain by spinal cord stimulation. The investigators will use commercially available device to deliver an intradural electrical stimulation to the spinal cord. This device is FDA approved for intracranial electrophysiological monitoring and delivery of electrical stimulation of the subsurface level of the brain.
As a part of the study, the subject will be offered to complete the following questionnaires to assess quality of life and global function. These questionnaires will be completed prior the procedure and at specified time periods following the research intervention. The experimental portion of the procedure will follow the standard epidural spinal cord stimulator testing. Under fluoroscopic guidance, using a paramedian approach and shallow entry angle, the device will be placed percutaneously at the lumbar spine at L2-3 or L3-4 level into the intrathecal cerebrospinal fluid (CSF) space and advanced to the T8-10 disc space. The stimulation catheter will run through a standardized experimental algorithm further described in greater details. The initial stimulation will last approximately 30 minutes and involve testing for paresthesias (tingling) and measurement of the threshold signal strength for onset of this sensation at 60 hertz (Hz) and 10000 Hz frequences. During this portion the subject will be asked to describe the sensations and rate his or her pain on a 0 to 10 scale. Following this initial stimulation, the frequency will be changed to 10 kilohertz (KHz) to run over the period of 4 hours. The investigators will continue evaluating the effects of stimulation using visual analogue scores during this period of time.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All subjects enrolled in this study will undergo Intradural Spinal Cord Stimulation.
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Device: Intradural Spinal Cord Stimulation, Behavioral: Administration of QuestionnairesIntradural Spinal Cord Stimulation; Administration of Questionnaires |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients with neuropathic pain and concordant neurological findings previously consented for an epidural spinal cord stimulator trial
- Patients greater than 18 years of agree
- Must have one of the following:
- Disease duration of at least 6 months with no lasting success with standard therapies or medications with exception of spinal cord stimulation
- Mean pain intensity of a least 5 (or greater) measured on a visual analogue scale from 0 (no pain) to 10 (severe pain)
Key exclusion criteria (19 listed)
- Patients who are unable or unwilling to provide feedback regarding the response
- Subject has an existing intrathecal drug pump
- Pain is attributed to: vascular disorder; musculoskeletal disorder; substance abuse or withdrawal; infection; disorder of homeostasis
- Subject is currently enrolled in another trial
- History of coagulation disorders or patients on chronic anticoagulant or antiplatelet therapy that is not able to be safely held for 14 days
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 |
|---|---|---|
| Intradural Spinal Cord StimulationThe device will be placed percutaneously at the lumbar spine at L2-3 or L3-4 level into the intrathecal CSF space and advanced to the T8-10 disc space. After positioning of the intrathecal lead, the stimulation catheter will be run through a standardized experimental algorithm consisting on various frequencies. | Device | Single Arm |
| Administration of QuestionnairesSubjects will be administered questionnaires to evaluate pain, quality of life, and global function prior the study, at 1 hour after the completion of the study, and at 4 day follow-up appointment. | Behavioural | Single Arm |
Primary outcome
Establishment of paresthesia threshold
Time frame: 30 minutes
Observe and record how various stimulation measures induce paresthesias and record this paresthesia threshold. This will be measured by having the patient state when they feel paresthesias as the stimulation amplitude is increased. This will be recorded as a raw number.
Establishment of motor threshold
Time frame: 30 minutes
Observe and record how various stimulation measures induce motor activity and record this motor threshold. This will be measured by having the patient state when they feel motor movement as the stimulation amplitude is increased. This will be recorded as a raw number.
Acute Adverse Pain Responses using short-form McGill Pain Questionnaire
Time frame: 5 hours
Demonstrate that intradural stimulation does not induce adverse painful responses during acute stimulation. Participants will be administered the short-form McGill Pain Questionnaire prior to start of testing and one hour following testing has concluded. The McGill Pain Questionnaire has a range of scores from zero (min) to 45(max) with lower numbers being better.
Acute Adverse Pain Responses using long form Brief pain inventory (BPI)
Time frame: 5 hours
Demonstrate that intradural stimulation does not induce adverse painful responses during acute stimulation. Participants will be administered the long form BPI prior to start of testing and one hour following testing has concluded. The brief pain index creates a severity and interference score that ranges from zero (min) and 10 (max) with lower numbers being better.
2 secondary outcomes
Difference in Stimulation Intensity to induce paresthesias
Time frame: 90 minutes
Unexpected/Chronic effects of stimulation
Time frame: 1 month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2021.
- Background: PubMed 17350527Charghi R, Chan SY, Kardash KJ, Finlayson RJ, Tran DQ. Electrical stimulation of the epidural space using a catheter with a removable stylet. Reg Anesth Pain Med. 2007 Mar-Apr;32(2):152-6. doi: 10.1016/j.rapm.2006.10.006.
- BackgroundCrews JC, Chan VWS. Perioperative management of patients and equipment selection for neural blockade. In: Cousins MJ, Horlocker TT, Bridenbaugh PO, Carr DB, Eds., Neural Blockade in Clinical Anesthesia and Pain Medicine (Wolters Kluwer, Philadelphia, 2009), Chap. 8, 160-180. ISBN-13: 978-0-7817-7388-1
- Background: PubMed 23151433Flouty O, Oya H, Kawasaki H, Wilson S, Reddy CG, Jeffery ND, Brennan TJ, Gibson-Corley KN, Utz M, Gillies GT, Howard MA 3rd. A new device concept for directly modulating spinal cord pathways: initial in vivo experimental results. Physiol Meas. 2012 Dec;33(12):2003-15. doi: 10.1088/0967-3334/33/12/2003. Epub 2012 Nov 15.
- Background: PubMed 24800260Gibson-Corley KN, Flouty O, Oya H, Gillies GT, Howard MA. Postsurgical pathologies associated with intradural electrical stimulation in the central nervous system: design implications for a new clinical device. Biomed Res Int. 2014;2014:989175. doi: 10.1155/2014/989175. Epub 2014 Apr 1.
- Background: PubMed 25536035Howell B, Lad SP, Grill WM. Evaluation of intradural stimulation efficiency and selectivity in a computational model of spinal cord stimulation. PLoS One. 2014 Dec 23;9(12):e114938. doi: 10.1371/journal.pone.0114938. eCollection 2014.
- Background: PubMed 15983148Lena P, Martin R. Subdural placement of an epidural catheter detected by nerve stimulation. Can J Anaesth. 2005 Jun-Jul;52(6):618-21. doi: 10.1007/BF03015772.
- Background: PubMed 21992159Pope JE, Stanton-Hicks M. Accidental subdural spinal cord stimulator lead placement and stimulation. Neuromodulation. 2011 Jan;14(1):30-2; discussion 33. doi: 10.1111/j.1525-1403.2010.00299.x. Epub 2010 Oct 7.
- Background: PubMed 26585728Reddy CG, Dalm BD, Flouty OE, Gillies GT, Howard MA 3rd, Brennan TJ. Comparison of Conventional and Kilohertz Frequency Epidural Stimulation in Patients Undergoing Trialing for Spinal Cord Stimulation: Clinical Considerations. World Neurosurg. 2016 Apr;88:586-591. doi: 10.1016/j.wneu.2015.10.088. Epub 2015 Nov 14.
- Background: PubMed 24654267Sharpe AN, Jackson A. Upper-limb muscle responses to epidural, subdural and intraspinal stimulation of the cervical spinal cord. J Neural Eng. 2014 Feb;11(1):016005. doi: 10.1088/1741-2560/11/1/016005.
- Background: PubMed 23975646Toma AK, Papadopoulos MC, Stapleton S, Kitchen ND, Watkins LD. Systematic review of the outcome of shunt surgery in idiopathic normal-pressure hydrocephalus. Acta Neurochir (Wien). 2013 Oct;155(10):1977-80. doi: 10.1007/s00701-013-1835-5. Epub 2013 Aug 23.
- Background: PubMed 10442964Tsui BC, Gupta S, Finucane B. Detection of subarachnoid and intravascular epidural catheter placement. Can J Anaesth. 1999 Jul;46(7):675-8. doi: 10.1007/BF03013957.
- Background: PubMed 27042909Williams MA, Malm J. Diagnosis and Treatment of Idiopathic Normal Pressure Hydrocephalus. Continuum (Minneap Minn). 2016 Apr;22(2 Dementia):579-99. doi: 10.1212/CON.0000000000000305.
- Individual participant dataSharing planned: Undecided
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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.
Matthew A Howard, MD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intradural Spinal Cord Stimulation and Administration of Questionnaires in people with Pain, Chronic, run by Matthew Howard 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 19 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: withdrawn, as of the sponsor's last update on 11 May 2021. 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 was withdrawn before enrolling participants, so there are no results.
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?
Establishment of paresthesia threshold (time frame: 30 minutes). The study lists 4 primary outcomes in all. 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 NCT03380104, which also lists 12 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 11 May 2021.