Not provided
Not provided
Not provided
Not provided
Not provided
Reassignment of PI to more intense clinical obligations prevents continuation of the trial.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lidocaine in SphenoCath device | Experimental | One treatment will be given. |
|
| Saline Solution in SphenoCath device | Placebo Comparator | One treatment will be given. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine in SphenoCath device | Combination 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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." | 48 hours pre-SPG to 48 hours after SPG block |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2, 24 hours after SPG block |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michael Popovich, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
Upon request, I will share de-identified participant demographic information, outcome data, study protocol, statistical analysis plan, and informed consent form.
The data will be made available within 6 months of the study's conclusion, and will remain available for at least 5 years thereafter.
Data will be made available if requested, pending a data use agreement.
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Lidocaine in SphenoCath Device | One treatment was given. Lidocaine in SphenoCath device: Participants received 2.5 cc of lidocaine 1% solution intranasally via a SphenoCath device into each nares. The portion of the procedure involving this device lasted approximately 30-60 seconds. |
| FG001 | Saline Solution in SphenoCath Device | One treatment was given. Saline Solution in SphenoCath device: Participants received saline solution via a SphenoCath device into each nares. The portion of the procedure involving this device lasted approximately 30-60 seconds. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Lidocaine in SphenoCath Device | One treatment was given. Lidocaine in SphenoCath device: Participants received 2.5 cc of lidocaine 1% solution intranasally via a SphenoCath device into each nares. The portion of the procedure involving this device lasted approximately 30-60 seconds. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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." | Because only one participant was involved in each arm, showing data could violate privacy interests. | Posted | 48 hours pre-SPG to 48 hours after SPG block |
|
2 Weeks: AE data was collected prior to and a week following procedure.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lidocaine in SphenoCath Device | One treatment was given. Lidocaine in SphenoCath device: Participants received 2.5 cc of lidocaine 1% solution intranasally via a SphenoCath device into each nares. The portion of the procedure involving this device lasted approximately 30-60 seconds. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Popovich | University of Michigan | (734) 936-1808 | mipopovi@med.umich.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 3, 2020 | Apr 22, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 3, 2020 | Aug 25, 2022 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| D006261 | Headache |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Saline Solution in SphenoCath device | Combination 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. |
|
| 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. |
| 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. | 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. | 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. | 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 | 48 hours pre SPG up to 48 hours post SPG |
| Mean Headache Hours Per Day Within 1 Week Pre and 1 Week Post Block | 1 week before SPG block to 1 week post SPG block |
| Mean Change in the Number of Days With Headache | 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. | 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. | 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. | 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. | 1 week before SPG block up to 1 week post SPG block |
| Saline Solution in SphenoCath Device |
One treatment was given. Saline Solution in SphenoCath device: Participants received saline solution via a SphenoCath device into each nares. The portion of the procedure involving this device lasted approximately 30-60 seconds. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
One treatment was given.
Saline Solution in SphenoCath device: Participants received saline solution via a SphenoCath device into each nares. The portion of the procedure involving this device lasted approximately 30-60 seconds.
|
| Secondary | 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. | Because only one participant was involved in each arm, showing data could violate privacy interests. | Posted | 2, 24 hours after SPG block |
|
|
| Secondary | 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. | Because only one participant was involved in each arm, showing data could violate privacy interests. | Posted | 1 week before SPG block, up to 1 week post SPG block |
|
|
| Secondary | 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. | Because only one participant was involved in each arm, showing data could violate privacy interests. | Posted | 48 hours pre SPG to 48 hours post block |
|
|
| Secondary | 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. | Because only one participant was involved in each arm, showing data could violate privacy interests. | Posted | 1 week before SPG block up to 1 week post SPG block |
|
|
| Secondary | 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. | Because only one participant was involved in each arm, showing data could violate privacy interests. | Posted | 1 week before SPG block, up to 1 week post SPG block |
|
|
| Secondary | Mean Headache Hours Per Day Within 48 Hours Pre- and 48 Hours Post-SPG Block | Because only one participant was involved in each arm, showing data could violate privacy interests. | Posted | 48 hours pre SPG up to 48 hours post SPG |
|
|
| Secondary | Mean Headache Hours Per Day Within 1 Week Pre and 1 Week Post Block | Because only one participant was involved in each arm, showing data could violate privacy interests. | Posted | 1 week before SPG block to 1 week post SPG block |
|
|
| Secondary | Mean Change in the Number of Days With Headache | Because only one participant was involved in each arm, showing data could violate privacy interests. | Posted | 1 week before SPG block, up to 1 week post SPG |
|
|
| Secondary | Mean Number of Days With Headache in the1 Week Post-SPG Block Compared to 1 Week Pre-SPG Block. | Because only one participant was involved in each arm, showing data could violate privacy interests. | Posted | 1 week before SPG block up to 1 week post SPG |
|
|
| Secondary | 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. | Because only one participant was involved in each arm, showing data could violate privacy interests. | Posted | 1 week before SPG block to 1 week post SPG block |
|
|
| Secondary | 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. | Because only one participant was involved in each arm, showing data could violate privacy interests. | Posted | 48 hours before SPG block to 48 hours post SPG block |
|
|
| Secondary | 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. | Because only one participant was involved in each arm, showing data could violate privacy interests. | Posted | 1 week before SPG block up to 1 week post SPG block |
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | Saline Solution in SphenoCath Device | One treatment was given. Saline Solution in SphenoCath device: Participants received saline solution via a SphenoCath device into each nares. The portion of the procedure involving this device lasted approximately 30-60 seconds. | 0 | 1 | 0 | 1 | 0 | 1 |
Not provided
Not provided
Not provided
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |