ConcussionPhase 2NCT04650282
Sphenopalatine Ganglion Block for Headache After Concussion
A Phase 2 study testing Lidocaine in SphenoCath device and Saline Solution in SphenoCath device in people with Concussion and Headache, run by University of Michigan at 1 site in United States.
Trial summary
This clinical trial will enroll participants to evaluate the effects of SPG block on post-traumatic headache. The study hypothesizes that patients that receive a SPG block with lidocaine vs. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Concussion, Headache
- What is being tested?
- Lidocaine in SphenoCath device and Saline Solution in SphenoCath device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2021to 6 Apr 2021
- Phase
- Phase 2
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed with a concussion and are greater than 14 days from the date of their injury.
- Experiencing greater or equal than 4 occurrences of headache per week lasting at least 1 hour per occurrence with a headache severity score greater or equal to 2 out of 6.
Who cannot join
- Allergy to local anesthetics of the amide type (for example (i.e.) lidocaine)
- Frequent epistaxis (i.e. more than one nose bleed per month),
- Bleeding disorders
- History of any of the following: nasal or facial fracture, nasal septal defect, any other craniofacial abnormality, hepatic disease, Adam-Stokes syndrome, Wolff-Parkinson-White syndrome, or severe degrees of sinoatrial, atrioventricular, or intraventricular heart block
- Pregnant
- Are at increased risk for methemoglobinemia (including patients with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, and concurrent exposure to oxidizing agents or their metabolites and drugs associated with methemoglobinemia)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Randomized Controlled Double-Blind Clinical Trial of Sphenopalatine Ganglion (SPG) Block for Headache After Concussion
This clinical trial will enroll participants to evaluate the effects of SPG block on post-traumatic headache. The study hypothesizes that patients that receive a SPG block with lidocaine vs. placebo (saline) will have a lower number of headache days in the week following the procedure, and will also report lower symptom scores.
Eligible participants will receive one treatment (SPG block) as well as complete surveys prior to and after receiving treatment (for a total of approximately 2 weeks).
- Conditions
- Concussion, Headache
- Being tested
- Lidocaine in SphenoCath device, Saline Solution in SphenoCath device
- Keywords
- Concussions, headaches, sphenopalatine ganglion block
- Medical subject headings
- Brain Concussion, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine in SphenoCath deviceCombination product
Participants will receive 2.5 cc of lidocaine 1% solution intranasally via a SphenoCath device into each nares.The portion of the procedure involving this device lasts approximately 30-60 seconds.
Saline Solution in SphenoCath deviceCombination product
Participants will receive saline solution via a SphenoCath device into each nares. The portion of the procedure involving this device lasts approximately 30-60 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine in SphenoCath device | Experimental | One treatment will be given. Receives: Combination Product: Lidocaine in SphenoCath device |
| Saline Solution in SphenoCath device | Placebo comparator | One treatment will be given. Receives: Combination Product: Saline Solution in SphenoCath device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Headache Severity Score
Patients will rate their headache on a scale of 0 to 6, with 0 corresponding to "absent" and 6 corresponding to "severe."
Measured: 48 hours pre-SPG to 48 hours after SPG block
Secondary outcomes (12)
Patient Global Impression of Change (PGIC)
A rating scale of global improvement which participants use a seven-point scale ("1" = very much improved, "4" = no change, "7" very much worse). Participants will rate their change at two hours and 24 hours following the SPG block procedure.
Measured: 2, 24 hours after SPG block
Mean Change in the Number of Headache Occurrences
The number of headache episodes over the one week prior to the SPG block compared to one week after the procedure.
Measured: 1 week before SPG block, up to 1 week post SPG block
Mean Headache Occurrences Within 48 Hours pre-and 48 Hours Post-SPG Block
The number of headache episodes prior to the SPG block to after the procedure.
Measured: 48 hours pre SPG to 48 hours post block
Mean Headache Occurrences Within 1 Week Pre- and 1 Week Post-SPG Block
The number of headache episodes over the one week prior to the SPG block to one week after the procedure.
Measured: 1 week before SPG block up to 1 week post SPG block
Mean Change in Headache Hours Per Day
The number hours with headache 1 week prior to the SPG block and for up to 1 week after the procedure.
Measured: 1 week before SPG block, up to 1 week post SPG block
Mean Headache Hours Per Day Within 48 Hours Pre- and 48 Hours Post-SPG Block
Measured: 48 hours pre SPG up to 48 hours post SPG
Mean Headache Hours Per Day Within 1 Week Pre and 1 Week Post Block
Measured: 1 week before SPG block to 1 week post SPG block
Mean Change in the Number of Days With Headache
Measured: 1 week before SPG block, up to 1 week post SPG
Mean Number of Days With Headache in the1 Week Post-SPG Block Compared to 1 Week Pre-SPG Block.
Measured: 1 week before SPG block up to 1 week post SPG
Mean Change in As-needed Headache Treatment Uses
Patients will be asked to report the number of uses of as-needed headache medications used in the one week prior to the SPG block and after SPG block for up to one week after the procedure.
Measured: 1 week before SPG block to 1 week post SPG block
Mean As-needed Headache Treatment Uses Within 48 Hours Pre- and 48 Hours Post-SPG
Patients will be asked to report the number of uses of as-needed headache medications used in the one week prior to the SPG block and after SPG block for up to one week after the procedure.
Measured: 48 hours before SPG block to 48 hours post SPG block
Mean As-needed Headache Treatment Uses Within 1 Week Pre and 1 Week Post Block
Patients will be asked to report the number of uses of as-needed headache medications used in the one week prior to the SPG block and after SPG block for up to one week after the procedure.
Measured: 1 week before SPG block up to 1 week post SPG block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start18 Mar 2021
- Primary completion1 Apr 2021
- Study completion6 Apr 2021
Why it stopped: Reassignment of PI to more intense clinical obligations prevents continuation of the trial.
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.
- Other trials for ConcussionStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Popovich, University of Michigan
- Investigators
- Michael Popovich, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04650282
- Sponsor's protocol ID
- HUM00185200
- Status last verified
- Aug 2022
- First submitted
- 24 Nov 2020
- Last updated
- 14 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Upon request, I will share de-identified participant demographic information, outcome data, study protocol, statistical analysis plan, and informed consent form.
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized Controlled Double-Blind Clinical Trial of Sphenopalatine Ganglion (SPG) Block for Headache After Concussion
- ClinicalTrials.gov ID
- NCT04650282
- Acronym / sponsor ID
- HUM00185200
- Conditions
- Concussion, Headache
- Keywords
- Concussions, headaches, sphenopalatine ganglion block
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Reassignment of PI to more intense clinical obligations prevents continuation of the trial.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 18 Mar 2021 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 6 Apr 2021 (actual)
- First posted
- 2 Dec 2020 (actual)
- Results
- Posted 18 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial will enroll participants to evaluate the effects of SPG block on post-traumatic headache. The study hypothesizes that patients that receive a SPG block with lidocaine vs. placebo (saline) will have a lower number of headache days in the week following the procedure, and will also report lower symptom scores.
Eligible participants will receive one treatment (SPG block) as well as complete surveys prior to and after receiving treatment (for a total of approximately 2 weeks).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine in SphenoCath device | Experimental | Combination Product: Lidocaine in SphenoCath deviceOne treatment will be given. |
| Saline Solution in SphenoCath device | Placebo comparator | Combination Product: Saline Solution in SphenoCath deviceOne treatment will be given. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Diagnosed with a concussion and are greater than 14 days from the date of their injury.
- Experiencing greater or equal than 4 occurrences of headache per week lasting at least 1 hour per occurrence with a headache severity score greater or equal to 2 out of 6.
Key exclusion criteria (6 listed)
- Allergy to local anesthetics of the amide type (for example (i.e.) lidocaine)
- Frequent epistaxis (i.e. more than one nose bleed per month),
- Bleeding disorders
- History of any of the following: nasal or facial fracture, nasal septal defect, any other craniofacial abnormality, hepatic disease, Adam-Stokes syndrome, Wolff-Parkinson-White syndrome, or severe degrees of sinoatrial, atrioventricular, or intraventricular heart block
- Pregnant
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 |
|---|---|---|
| Lidocaine in SphenoCath deviceParticipants will receive 2.5 cc of lidocaine 1% solution intranasally via a SphenoCath device into each nares.The portion of the procedure involving this device lasts approximately 30-60 seconds. | Combination product | Lidocaine in SphenoCath device |
| Saline Solution in SphenoCath deviceParticipants will receive saline solution via a SphenoCath device into each nares. The portion of the procedure involving this device lasts approximately 30-60 seconds. | Combination product | Saline Solution in SphenoCath device |
Primary outcome
Mean Change in Headache Severity Score
Time frame: 48 hours pre-SPG to 48 hours after SPG block
Patients will rate their headache on a scale of 0 to 6, with 0 corresponding to "absent" and 6 corresponding to "severe."
12 secondary outcomes
Patient Global Impression of Change (PGIC)
Time frame: 2, 24 hours after SPG block
Mean Change in the Number of Headache Occurrences
Time frame: 1 week before SPG block, up to 1 week post SPG block
Mean Headache Occurrences Within 48 Hours pre-and 48 Hours Post-SPG Block
Time frame: 48 hours pre SPG to 48 hours post block
Mean Headache Occurrences Within 1 Week Pre- and 1 Week Post-SPG Block
Time frame: 1 week before SPG block up to 1 week post SPG block
Mean Change in Headache Hours Per Day
Time frame: 1 week before SPG block, up to 1 week post SPG block
Mean Headache Hours Per Day Within 48 Hours Pre- and 48 Hours Post-SPG Block
Time frame: 48 hours pre SPG up to 48 hours post SPG
Mean Headache Hours Per Day Within 1 Week Pre and 1 Week Post Block
Time frame: 1 week before SPG block to 1 week post SPG block
Mean Change in the Number of Days With Headache
Time frame: 1 week before SPG block, up to 1 week post SPG
Mean Number of Days With Headache in the1 Week Post-SPG Block Compared to 1 Week Pre-SPG Block.
Time frame: 1 week before SPG block up to 1 week post SPG
Mean Change in As-needed Headache Treatment Uses
Time frame: 1 week before SPG block to 1 week post SPG block
Mean As-needed Headache Treatment Uses Within 48 Hours Pre- and 48 Hours Post-SPG
Time frame: 48 hours before SPG block to 48 hours post SPG block
Mean As-needed Headache Treatment Uses Within 1 Week Pre and 1 Week Post Block
Time frame: 1 week before SPG block up to 1 week post SPG block
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Upon request, I will share de-identified participant demographic information, outcome data, study protocol, statistical analysis plan, and informed consent form.
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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.
Michael Popovich, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lidocaine in SphenoCath device and Saline Solution in SphenoCath device in people with Concussion and Headache, run by University of Michigan 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 2 inclusion and 6 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: stopped early, as of the sponsor's last update on 14 Sep 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. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 May 2022). 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?
Mean Change in Headache Severity Score (time frame: 48 hours pre-SPG to 48 hours after SPG block). 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 14 Sep 2022.