- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03263884
Repetitive Transcranial Magnetic Stimulation and the Development of Ongoing Muscle Pain
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Nordjylland
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Aalborg, Nordjylland, Denmark, 9000
- Aalborg University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Real treatment group
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. |
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.
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Sham Comparator: Sham treatment group
Sham coil is used to mimic the clicking sound of the TMS coil and skin stimulation
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A sham coil is used to mimic the clicking sound of the trancranial magnetic coil and skin stimulation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain relief
Time Frame: Change from baseline at 2 weeks
|
Pain on an 11-point numerical rating scale (0 = no pain, 10 = most intense pain imaginable)
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Change from baseline at 2 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Muscle soreness
Time Frame: Change from baseline at 2 weeks
|
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'
|
Change from baseline at 2 weeks
|
Patient-rated Tennis Elbow Evaluation
Time Frame: Change from baseline at 2 weeks
|
The Patient-rated Tennis Elbow Evaluation will be used to assess average pain and disability of the injected arm
|
Change from baseline at 2 weeks
|
Pressure pain thresholds
Time Frame: Change from baseline at 2 weeks
|
Pressure applied to the surface of the skin using a handheld algometer.
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Change from baseline at 2 weeks
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Attention network test
Time Frame: Change from baseline at 2 weeks
|
This task assesses cognitive function in 3 domains: alerting, orienting, and executive function
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Change from baseline at 2 weeks
|
Cuff pressure algometry
Time Frame: Change from baseline at 2 weeks
|
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.
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Change from baseline at 2 weeks
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EEG recordings
Time Frame: Change from baseline at 1 weeks
|
we will record brain activity in the following conditions: eyes closed rest, performance of a computer-based cognitive task (ANT).
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Change from baseline at 1 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Enrico De Martino, MD, Aalborg University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- N-20170041
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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