The Effect of Transcutaneous Magnetic Stimulation on Acute Pain.

Pain Perception Clinical Trial

Official title:

Investigation of the Effect of Transcranial Magnetic Stimulation of Several Sites in the Brain Upon Experimental Pain

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03777137
• Other study ID #: NA_00084600
• Status: Withdrawn
• 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
• 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.

Related Conditions & MeSH terms

• Pain Perception

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