Back to resultsRepetitive Transcranial Magnetic Stimulation and the Development of Ongoing Muscle Pain
Primary Purpose
Pain Relief
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Repetitive trancranial magnetic stimulation (rTMS) group
Sham group
Sponsored by
About this trial
This is an interventional treatment trial for Pain Relief focused on measuring nerve growth factor, repetitive transcranial magnetic stimulation, dorsolateral prefrontal cortex
Eligibility Criteria
Inclusion Criteria:
- Healthy men and women
- Speak and understand English.
Exclusion Criteria:
- Pregnancy
- Drug addiction defined as the use of cannabis, opioids or other drugs
- Previous neurologic, musculoskeletal or mental illnesses
- Lack of ability to cooperate
- History of chronic pain or current acute pain
- Previous experience with rTMS
- Contraindications to rTMS application (history of epilepsy, metal in the head or jaw etc.).
- Failure to pass the "TASS questionnaire" (TASS = Transcranial Magnetic Stimulation Adult Safety Screen)
Sites / Locations
- Aalborg University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Real treatment group
Sham treatment group
Arm Description
Transcranial magnetic stimulation (TMS) is used to stimulate small regions of the brain. During a TMS procedure, a magnetic field generator, or "coil", is placed near the head of the person receiving the treatment. The coil produces small electric currents in the region of the brain just under the coil via electromagnetic induction. The protocol used in this research includes 20 minutes of 10Hz stimulation, 5 seconds on, 10 seconds off, at 110% RMT, for a total of 4000 pulses.
Sham coil is used to mimic the clicking sound of the TMS coil and skin stimulation
Outcomes
Primary Outcome Measures
Pain relief
Pain on an 11-point numerical rating scale (0 = no pain, 10 = most intense pain imaginable)
Secondary Outcome Measures
Muscle soreness
7-point Likert scale; 0 = 'a complete absence of soreness', 1 = 'a light soreness in the muscle felt only when touched/vague ache', 2 = 'a moderate soreness felt only when touched/a slight persistent ache', '3 = 'a light muscle soreness when lifting or carrying objects', 4 = 'a light muscle soreness, stiffness or weakness when moving the wrist without gripping an object', 5 = 'a moderate muscle soreness, stiffness or weakness when moving the wrist', 6 = 'a severe muscle soreness, stiffness or weakness that limits the ability to move'
Patient-rated Tennis Elbow Evaluation
The Patient-rated Tennis Elbow Evaluation will be used to assess average pain and disability of the injected arm
Attention network test
This task assesses cognitive function in 3 domains: alerting, orienting, and executive function
Pressure pain thresholds
Pressure applied to the surface of the skin using a handheld algometer.
Cuff pressure algometry
The experimental setup consists of a tourniquet cuff, a computer-controlled air compressor and an electronic visual analog scale VAS (Aalborg University, Denmark). The cuff is connected to the compressor and wrapped around the leg. The pain intensity is recorded with the electronic VAS and sampled at 10 Hz. The "0 cm" and "10 cm" extremes on the VAS are defined as "no pain" and as "maximal pain", respectively. The compression rate of the cuff is programmed on and controlled by a computer.
EEG recordings
we will record brain activity in the following conditions: eyes closed rest, performance of a computer-based cognitive task (ANT).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03263884
Brief Title
Repetitive Transcranial Magnetic Stimulation and the Development of Ongoing Muscle Pain
Official Title
Repetitive Transcranial Magnetic Stimulation and the Development of Ongoing Muscle Pain
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
November 30, 2017 (Actual)
Study Completion Date
February 28, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aalborg University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The main purpose of the study is to assess the mechanisms of repeated sessions of repetitive trancranial magnetic stimulation (rTMS) applied on left dorsolateral prefrontal cortex on the development of pain in a prolonged muscle pain model.
Detailed Description
This study aims to investigate whether i) rTMS of left DLPFC will reduce the severity and duration of experimentally induced muscle pain when a 5-day course of treatment is given immediately following an initial nerve growth factor (NGF) injection; ii) the analgesic effects of left DLPFC rTMS will be related to an improved cognitive network function as assessed by electroencephalography (EEG).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain Relief
Keywords
nerve growth factor, repetitive transcranial magnetic stimulation, dorsolateral prefrontal cortex
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Real treatment group
Arm Type
Experimental
Arm Description
Transcranial magnetic stimulation (TMS) is used to stimulate small regions of the brain. During a TMS procedure, a magnetic field generator, or "coil", is placed near the head of the person receiving the treatment. The coil produces small electric currents in the region of the brain just under the coil via electromagnetic induction.
The protocol used in this research includes 20 minutes of 10Hz stimulation, 5 seconds on, 10 seconds off, at 110% RMT, for a total of 4000 pulses.
Arm Title
Sham treatment group
Arm Type
Sham Comparator
Arm Description
Sham coil is used to mimic the clicking sound of the TMS coil and skin stimulation
Intervention Type
Device
Intervention Name(s)
Repetitive trancranial magnetic stimulation (rTMS) group
Intervention Description
Repetitive trancranial magnetic stimulation is applied on the dorsolateral prefrontal cortex. The protocol consists on 20 minutes of 10Hz stimulation, 5 seconds on, 10 seconds off, at 110% RMT, for a total of 4000 pulses.
Intervention Type
Device
Intervention Name(s)
Sham group
Intervention Description
A sham coil is used to mimic the clicking sound of the trancranial magnetic coil and skin stimulation.
Primary Outcome Measure Information:
Title
Pain relief
Description
Pain on an 11-point numerical rating scale (0 = no pain, 10 = most intense pain imaginable)
Time Frame
Change from baseline at 2 weeks
Secondary Outcome Measure Information:
Title
Muscle soreness
Description
7-point Likert scale; 0 = 'a complete absence of soreness', 1 = 'a light soreness in the muscle felt only when touched/vague ache', 2 = 'a moderate soreness felt only when touched/a slight persistent ache', '3 = 'a light muscle soreness when lifting or carrying objects', 4 = 'a light muscle soreness, stiffness or weakness when moving the wrist without gripping an object', 5 = 'a moderate muscle soreness, stiffness or weakness when moving the wrist', 6 = 'a severe muscle soreness, stiffness or weakness that limits the ability to move'
Time Frame
Change from baseline at 2 weeks
Title
Patient-rated Tennis Elbow Evaluation
Description
The Patient-rated Tennis Elbow Evaluation will be used to assess average pain and disability of the injected arm
Time Frame
Change from baseline at 2 weeks
Title
Attention network test
Description
This task assesses cognitive function in 3 domains: alerting, orienting, and executive function
Time Frame
Change from baseline at 2 weeks
Title
Pressure pain thresholds
Description
Pressure applied to the surface of the skin using a handheld algometer.
Time Frame
Change from baseline at 2 weeks
Title
Cuff pressure algometry
Description
The experimental setup consists of a tourniquet cuff, a computer-controlled air compressor and an electronic visual analog scale VAS (Aalborg University, Denmark). The cuff is connected to the compressor and wrapped around the leg. The pain intensity is recorded with the electronic VAS and sampled at 10 Hz. The "0 cm" and "10 cm" extremes on the VAS are defined as "no pain" and as "maximal pain", respectively. The compression rate of the cuff is programmed on and controlled by a computer.
Time Frame
Change from baseline at 2 weeks
Title
EEG recordings
Description
we will record brain activity in the following conditions: eyes closed rest, performance of a computer-based cognitive task (ANT).
Time Frame
Change from baseline at 1 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy men and women
Speak and understand English.
Exclusion Criteria:
Pregnancy
Drug addiction defined as the use of cannabis, opioids or other drugs
Previous neurologic, musculoskeletal or mental illnesses
Lack of ability to cooperate
History of chronic pain or current acute pain
Previous experience with rTMS
Contraindications to rTMS application (history of epilepsy, metal in the head or jaw etc.).
Failure to pass the "TASS questionnaire" (TASS = Transcranial Magnetic Stimulation Adult Safety Screen)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enrico De Martino, MD
Organizational Affiliation
Aalborg University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aalborg University
City
Aalborg
State/Province
Nordjylland
ZIP/Postal Code
9000
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Repetitive Transcranial Magnetic Stimulation and the Development of Ongoing Muscle Pain
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