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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03777137
Other study ID # NA_00084600
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date October 1, 2021
Est. completion date July 1, 2027

Study information

Verified date October 2021
Source Johns Hopkins University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a single institution, single-blinded, long-term exploratory study using participant as his/her own control to evaluate and compare the potential analgesic effect on experimental heat pain of Transcutaneous Magnetic Stimulation (TMS). TMS will be delivered by a commercially available device (Rapid2, Magstim Corp) at three different cortical target sites and one sham target site in healthy participants 18-88 years of age. The quantitative evaluation measure is the change in the painful heat threshold Quantitative Sensory Testing (QST) of thresholds for cutaneous heat stimuli before and after TMS.


Description:

After subjects contact the office to express interest in being involved with this protocol, subjects will take the telephone screening questionnaire. Those who meet inclusion criteria with no exclusions will come for first visit. At this visit, subjects will discuss and sign the consent form, and have a one sequence MRI scan which is used to localize sites in the brain to be stimulated with TMS. The subjects will then have four visits at intervals of two weeks; each visit will have TMS intervention designated (SITE1), (SITE2), (SITE3), and (SITE4). TMS will be applied each of four sites (SITE1, SITE2, SITE3, and SITE4) which will be randomly assigned among stimulation sites Medial Frontal (MF), Dorsolateral Frontal (DL), Primary Motor Cortex (M1 and superior Interparietal sulcus (Sham) and counterbalanced across subjects (see Diagram below). During each of visits 2 to 5, the participant will undergo baseline Quantitative Sensory Testing (QST), followed by TMS stimulation and then by repeat QST. QST will consist of pain thresholds for cutaneous hot stimuli. Visits 2 through 5 will last for approximately 1 hour each and will occur at two-week intervals. The total study duration will be 50 days for each subject. Study enrollment will last for three years and total study duration will be four years.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date July 1, 2027
Est. primary completion date July 1, 2027
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Healthy man or woman 18-80 years of age; - Possess the ability to understand study procedures and comply with them for the entire length of the study; - Women of childbearing age must use contraception for duration of study. Exclusion Criteria: - History of diagnosis of heart disease, increased intracranial pressure, or structural abnormalities of the brain (e.g. tumor); - History of epilepsy, seizure disorder, neurologic disease, cranial trauma or head surgery, or implanted hardware (including cardiac pacemakers, cardiac lines, medication pumps, or stimulators); - Family history of seizures; - Presence of metal anywhere deep to or on the skull (excluding the mouth); - Any current or recent (<6 weeks) or planned (within duration of study period) use of any of the following medications: imipramine, amitriptyline, doxepin, nortriptyline, maprotiline, chlorpromazine, clozapine, foscarnet, ganciclovir, ritonavir, amphetamines, ketamine, gamma-hydroxybutyrate (GHB), and theophylline; - History of peripheral neuropathy, e.g. Diabetic Neuropathy; - Women who are pregnant or women of childbearing capacity who may become pregnant (i.e. not using contraception); - Volunteers with communication disorders or non-English speakers; - Current drug or alcohol use or dependence that, in the opinion of the investigators, would interfere with adherence to study requirements.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
TMS (Rapid2, Magstim Corp)
Volunteers will take a telephone screening questionnaire and those meeting inclusion criteria will attend their first visit. Those signing the consent will have a T1 weighted MRI scan to localize sites in the brain to be stimulated with TMS. The subjects will then have four visits at intervals of two weeks; each visit will have a TMS intervention including SITE1, SITE2, SITE3, and SITE4. The sequence of the testing TMS four different visits (SITE1 to SITE4) will be randomly assigned among stimulation sites Medial Frontal (MF), Dorsal Lateral Frontal (DL), Primary motor cortex (M1) and Interparietal Sulcus (Sham) and counterbalanced across subjects (see Diagram below). During each of visits 2 to 5, each participant will undergo baseline Quantitative Sensory Testing (QST), followed by a TMS intervention, and then by repeat QST. QST will consist of pain thresholds for contact heat.

Locations

Country Name City State
United States Hopkiins Functional Neurosurgery Lab Baltimore Maryland

Sponsors (2)

Lead Sponsor Collaborator
Johns Hopkins University University of Maryland, College Park

Country where clinical trial is conducted

United States, 

References & Publications (1)

. Lenz FA, Casey KL, Jones EG, Willis WD, The human pain system: experimental and clinical perspectives. Cambridge, UK ; New York: Cambridge University Press; 2010.

Outcome

Type Measure Description Time frame Safety issue
Primary Contact Heat Pain Temperature Threshold Change The contact heat thermal thermode will be used to measure heat pain thresholds (in degrees centigrade) before and after each stimulation site. Entire duration of study, approximately five years
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