The Effect of Transcutaneous Magnetic Stimulation on Acute Pain.

NCT03777137 | Withdrawn

• 1 other identifier: NA_00084600
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain Perception

Keywords

Brain network for pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

TMS during heat pain stimuli

This is a single institution, single-blinded, long-term exploratory study using participant as his/her own control to evaluate and compare the analgesic effect of experimental heat pain of TMS during early versus late times on a vigilance behaviors toward pain (CPT, Continuous Performance Task). Vigilance behaviors include errors, reaction times and activation.

Behavioral: TMS (Rapid2, Magstim Corp)

Interventions

TMS (Rapid2, Magstim Corp) BEHAVIORAL

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.

TMS during heat pain stimuli

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will include healthy men and women between 18 and 80 years of age with no history or family history of seizures. In addition, subjects cannot be taking pro-epileptic medications or have metal objects in the head except the mouth, as described in the telephone screening questionnaire.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• University of Maryland, College Park: collaborator

Study Sites (1)

Hopkiins Functional Neurosurgery Lab

Baltimore, Maryland, 21212, United States

Location

Related 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.

  BACKGROUND

Study Officials

• Frederick Lenz

  Department of Neurosurgery, JHU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2018
• First Posted: December 17, 2018
• Study Start: October 1, 2021
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: October 14, 2021

Record last verified: 2021-10

Locations

US (1)