NCT04545892

Brief Summary

To determine the safety and effect of crescent doses of capsaicin upon serial transcranial Doppler (TCD) markers of cerebral blood flow (CBF). Methods We performed serial TCD testing in 30 healthy volunteers divided into five equal groups. Capsaicin doses ranged from 33 to 165 μMol. We recorded peak systolic and end-diastolic velocities in the middle cerebral artery (MCA), arterial pressure, and perceived pungency (PP) in five minutes intervals up to 20 minutes. We then calculated the mean velocity (MV), the pulsatility index (PI), and the CBF index.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P50-P75 for phase_1 stroke

Timeline
Completed

Started Dec 2019

Shorter than P25 for phase_1 stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 4, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 11, 2020

Completed
Last Updated

September 11, 2020

Status Verified

September 1, 2020

Enrollment Period

8 months

First QC Date

September 4, 2020

Last Update Submit

September 10, 2020

Conditions

Stroke

Outcome Measures

Primary Outcomes (2)

  • Mean velocity

    The Mean velocity in the Middle Cerebral Artery

    20 minutes

  • Pulsatility Index

    A calculated flow parameter in ultrasound, derived from the maximum, minimum, and mean Doppler frequency shifts during a defined cardiac cycle.

    20 minutes

Secondary Outcomes (2)

  • Mean arterial pressure (MAP)

    20 minutes

  • Cerebral Blood Flow index

    20 minutes

Study Arms (1)

Capsaicin

EXPERIMENTAL

From an initial 0.1% capsaicin (Sigma-Aldrich, St. Louis, MO) stock solution in 95% ethanol; we prepared solutions with 33, 66, 99, 132 and 165 μMol/ml by diluting the stock solution with distilled water. We consecutively tested 6 participants for each dose of capsaicin alternating the stimulated side of the palate.

Drug: Capsaicin

Interventions

CapsaicinDRUG

One milliliter of each dilution was pipetted on to 2 cm filter paper squares. Then, the filter papers were let dry. Immediately before application, they were rehydrated with 1 milliliter of distilled water

Also known as: 8-Methyl-N-vanillyl-trans-6-nonenamide
Capsaicin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Those willing to participate with signed the informed consent form (ICF)
  • No diagnosis of any chronic or acute disorder

You may not qualify if:

  • Eating or drinking at least one h before the measurements
  • Eating spicy food for one day before testing.
  • Hypertension
  • Smoking
  • Any disorder of the oral cavity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unidad de Medicina de Alta Especialidad en Torre Médica CMQ

Aguascalientes, Aguascalientes, 20234, Mexico

Location

Related Publications (1)

  • Marquez-Romero JM, Huerta-Franco MR, Vargas-Luna M, Madrigal-Gutierrez CA, Esparza-Hernandez JM, Velazquez-Barcena MG. Dose Escalation and Safety of Capsaicin for Cerebral Perfusion Augmentation: A Pilot Study. Stroke. 2021 Jul;52(7):2203-2209. doi: 10.1161/STROKEAHA.120.032773. Epub 2021 May 10.

    PMID: 33966493DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Capsaicin

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Polyunsaturated AlkamidesAmidesOrganic ChemicalsAlkenesHydrocarbons, AcyclicHydrocarbonsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicSolanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsFatty Acids, MonounsaturatedFatty Acids, UnsaturatedFatty AcidsLipids

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 4, 2020

First Posted

September 11, 2020

Study Start

December 1, 2019

Primary Completion

July 31, 2020

Study Completion

July 31, 2020

Last Updated

September 11, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will share

Data will be shared with any qualified investigator upon request to the PI after signing a data use agreement.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
1 year
Access Criteria
any qualified investigator in the field

Locations

ME(1)