- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02608463
Neuropathic Pain in Pregnancy
Study Overview
Status
Intervention / Treatment
- Behavioral: painDETECT Questionnaire
- Behavioral: Pain Catastrophizing Scale
- Behavioral: Pain Intensity Scale, Pain Interference Scale, Pain Behavior Scale
- Behavioral: Beck Depression Inventory
- Behavioral: Visual Analogue Scale
- Behavioral: Patient's Global Impression of Change Scale & Clinical Global Impression-Global Improvement Scale
- Device: Transcranial Magnetic Stimulation
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Arkansas
-
Little Rock, Arkansas, United States, 72205
- University of Arkansas for Medical Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Part A
Inclusion Criteria:
- age 18-45 years old,
- ability to give informed consent,
- viable pregnancy, and
- enrollment prior or equal to 24 weeks gestation
Exclusion Criteria:
- Active or history of substance use disorder within the past year
- Non-English speaking
Part B
Inclusion Criteria:
- Subjects enrolled in Part A and willing to consent to Part B of this protocol
- Pregnant with current chronic neuropathic pain
Subjects failed treatment with amitriptyline or nortriptyline as defined by one of the following:
- no clinical improvement following a 4-week trial of amitriptyline or nortriptyline (i.e., CGI-I score ≥4)
- an inability to tolerate the medication (i.e., side effects)
- Subjects must pass the TMS Safety Checklist Adult Safety Screen (TASS).
- Subjects should be off medication, which can lower seizure thresholds (e.g., amitriptyline and nortriptyline) for at least two weeks prior to study entry.
- Subjects with neuropathic pain including those with diagnosis of spinal cord injury, fibromyalgia, compression neuropathies (including diabetic peripheral neuropathy), post stroke pain, and multiple sclerosis
- Subjects with a baseline VAS score greater than 30
Exclusion Criteria:
- Current or past history of a seizure disorder (e.g., epilepsy)
- Current history of preeclampsia
- Current or history of brain lesions (e.g., aneurysm)
- History of major head trauma (e.g., stroke; previous cranial neurosurgery)
- Ferromagnetic metal in the head, neck, or chest (e.g., plates or pins, bullets, shrapnel)
- Microprocessor implants in the head (e.g., cochlear implants) or life-sustaining microprocessor implants anywhere in the body (e.g., prosthetic cardiac valves)
- Cardiac pacemaker
- Active or inactive implants (e.g., deep brain stimulators, vagus nerve stimulators)
- Active treatment with medications that lower seizure threshold (e.g., bupropion, amitriptyline, nortriptyline, or other TCA)
- Increased intracranial pressure (which lowers seizure threshold)
- Implanted medication pumps
- Intracardiac lines
- Significant heart disease defined as heart disease that causes moderate to severe symptoms and/or is characterized by moderate to severe pathology, including a recent history of myocardial infarction and heart failure with an ejection fraction of less than 30% or with a New York Heart Association Functional Classification of Class III or IV.
- Bipolar disorder (to reduce the risk of mania)
- History of suicide attempt(s)
- Family history of epilepsy
- Heavy alcohol consumption within the past 48 hours
- Permanent makeup or tattoos with metallic dyes
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Part A - Neuropathic Pain
Subjects with a score of ≥ 13 on the painDETECT Questionnaire (PDQ) will be assigned to the Neuropathic Pain group.
|
This self-report questionnaire consists of 7 questions that address the quality of neuropathic pain syndromes.
The first 5 questions ask about the gradation of pain, question 6 asks about the pain course pattern and question 7 asks about radiating pain.
There are 4 additional questions (not counted in the total score) which asks the subject to rate their pain now and over the last 4 weeks and to mark on a body chart if there is pain radiating into other parts of the body.
Other Names:
The PCS is a 13-item self-report scale.
It asks subjects to reflect on past painful experiences, and to indicate the degree to which they experienced each of 13 thoughts or feelings when experiencing pain, on 5-point scales with the end points (0) not at all and (4) all the time.
The PCS yields a total score and three subscale scores assessing rumination, magnification, and helplessness.
Other Names:
The 3-item, self-report Pain Intensity assesses how much a person hurts. The first 2 items assess pain intensity over the past 7 days; the last item asks subject to rate pain intensity "right now." The 4-item, self-report Pain Interference measures the consequences of pain on relevant aspects of subject's life. It includes impairment in subject's social, cognitive, emotional, physical, & recreational activities. It also incorporates items about sleep and enjoyment of life. It assesses pain interference over the past 7 days. The 7-item, self-report Pain Behavior measures behaviors that typically indicate to others that an individual is experiencing pain. Measures include observations (sighing, crying), behaviors (resting, guarding, facial expressions, asking for help), & verbal reports of pain. It assesses pain interference over the past 7 days. All three scales, derived from the Patient Reported Outcomes Measurement Information System (PROMIS), are not disease specific.
Other Names:
The BDI is a widely used instrument that has been used in both clinical and non-clinical setting measuring depressive symptoms.
It is a 21 item questionnaire with 4-5 responses for each question.
Responses are coded 0-3 for the 4 point scales.
The 5 point scales include an additional 2a and 2b response code.
The symptom categories reflect overt behavioral manifestations of depression.
The instrument has both a high degree of reliability and validity (Beck, Ward, Mendelson, Mock & Erbaugh, 1961).
Other Names:
100 mm line scale that is subject administered to subjectively rate current pain symptoms.
The subject will be instructed to draw a single vertical line that best describes current state.
Other Names:
The PGIC gives a global rating of change in symptoms, activities, emotion, and overall quality of life related to the subject's pain condition. This is a self-rated scale. The CGI-I gives a global rating of the improvement/change in the symptoms since the last study visit. This is administered by the MD.
Other Names:
|
Other: Part A - Non-Neuropathic Pain
Subjects with a score of ≥ 1 or ≤ 12 on the painDETECT Questionnaire (PDQ) will be assigned to the Non-Neuropathic Pain group.
|
This self-report questionnaire consists of 7 questions that address the quality of neuropathic pain syndromes.
The first 5 questions ask about the gradation of pain, question 6 asks about the pain course pattern and question 7 asks about radiating pain.
There are 4 additional questions (not counted in the total score) which asks the subject to rate their pain now and over the last 4 weeks and to mark on a body chart if there is pain radiating into other parts of the body.
Other Names:
The PCS is a 13-item self-report scale.
It asks subjects to reflect on past painful experiences, and to indicate the degree to which they experienced each of 13 thoughts or feelings when experiencing pain, on 5-point scales with the end points (0) not at all and (4) all the time.
The PCS yields a total score and three subscale scores assessing rumination, magnification, and helplessness.
Other Names:
The 3-item, self-report Pain Intensity assesses how much a person hurts. The first 2 items assess pain intensity over the past 7 days; the last item asks subject to rate pain intensity "right now." The 4-item, self-report Pain Interference measures the consequences of pain on relevant aspects of subject's life. It includes impairment in subject's social, cognitive, emotional, physical, & recreational activities. It also incorporates items about sleep and enjoyment of life. It assesses pain interference over the past 7 days. The 7-item, self-report Pain Behavior measures behaviors that typically indicate to others that an individual is experiencing pain. Measures include observations (sighing, crying), behaviors (resting, guarding, facial expressions, asking for help), & verbal reports of pain. It assesses pain interference over the past 7 days. All three scales, derived from the Patient Reported Outcomes Measurement Information System (PROMIS), are not disease specific.
Other Names:
The BDI is a widely used instrument that has been used in both clinical and non-clinical setting measuring depressive symptoms.
It is a 21 item questionnaire with 4-5 responses for each question.
Responses are coded 0-3 for the 4 point scales.
The 5 point scales include an additional 2a and 2b response code.
The symptom categories reflect overt behavioral manifestations of depression.
The instrument has both a high degree of reliability and validity (Beck, Ward, Mendelson, Mock & Erbaugh, 1961).
Other Names:
100 mm line scale that is subject administered to subjectively rate current pain symptoms.
The subject will be instructed to draw a single vertical line that best describes current state.
Other Names:
The PGIC gives a global rating of change in symptoms, activities, emotion, and overall quality of life related to the subject's pain condition. This is a self-rated scale. The CGI-I gives a global rating of the improvement/change in the symptoms since the last study visit. This is administered by the MD.
Other Names:
|
Other: Part A - Control
Subjects with a score of score = 0 on the painDETECT Questionnaire (PDQ) will be assigned to the Control group.
|
This self-report questionnaire consists of 7 questions that address the quality of neuropathic pain syndromes.
The first 5 questions ask about the gradation of pain, question 6 asks about the pain course pattern and question 7 asks about radiating pain.
There are 4 additional questions (not counted in the total score) which asks the subject to rate their pain now and over the last 4 weeks and to mark on a body chart if there is pain radiating into other parts of the body.
Other Names:
The PCS is a 13-item self-report scale.
It asks subjects to reflect on past painful experiences, and to indicate the degree to which they experienced each of 13 thoughts or feelings when experiencing pain, on 5-point scales with the end points (0) not at all and (4) all the time.
The PCS yields a total score and three subscale scores assessing rumination, magnification, and helplessness.
Other Names:
The 3-item, self-report Pain Intensity assesses how much a person hurts. The first 2 items assess pain intensity over the past 7 days; the last item asks subject to rate pain intensity "right now." The 4-item, self-report Pain Interference measures the consequences of pain on relevant aspects of subject's life. It includes impairment in subject's social, cognitive, emotional, physical, & recreational activities. It also incorporates items about sleep and enjoyment of life. It assesses pain interference over the past 7 days. The 7-item, self-report Pain Behavior measures behaviors that typically indicate to others that an individual is experiencing pain. Measures include observations (sighing, crying), behaviors (resting, guarding, facial expressions, asking for help), & verbal reports of pain. It assesses pain interference over the past 7 days. All three scales, derived from the Patient Reported Outcomes Measurement Information System (PROMIS), are not disease specific.
Other Names:
The BDI is a widely used instrument that has been used in both clinical and non-clinical setting measuring depressive symptoms.
It is a 21 item questionnaire with 4-5 responses for each question.
Responses are coded 0-3 for the 4 point scales.
The 5 point scales include an additional 2a and 2b response code.
The symptom categories reflect overt behavioral manifestations of depression.
The instrument has both a high degree of reliability and validity (Beck, Ward, Mendelson, Mock & Erbaugh, 1961).
Other Names:
100 mm line scale that is subject administered to subjectively rate current pain symptoms.
The subject will be instructed to draw a single vertical line that best describes current state.
Other Names:
The PGIC gives a global rating of change in symptoms, activities, emotion, and overall quality of life related to the subject's pain condition. This is a self-rated scale. The CGI-I gives a global rating of the improvement/change in the symptoms since the last study visit. This is administered by the MD.
Other Names:
|
Experimental: Part B - rTMS
Subjects from the Neuropathic Pain group will be invited to participate in the Part B rTMS group to receive repetitive transcranial magnetic stimulation (rTMS).
|
The BDI is a widely used instrument that has been used in both clinical and non-clinical setting measuring depressive symptoms.
It is a 21 item questionnaire with 4-5 responses for each question.
Responses are coded 0-3 for the 4 point scales.
The 5 point scales include an additional 2a and 2b response code.
The symptom categories reflect overt behavioral manifestations of depression.
The instrument has both a high degree of reliability and validity (Beck, Ward, Mendelson, Mock & Erbaugh, 1961).
Other Names:
100 mm line scale that is subject administered to subjectively rate current pain symptoms.
The subject will be instructed to draw a single vertical line that best describes current state.
Other Names:
The PGIC gives a global rating of change in symptoms, activities, emotion, and overall quality of life related to the subject's pain condition. This is a self-rated scale. The CGI-I gives a global rating of the improvement/change in the symptoms since the last study visit. This is administered by the MD.
Other Names:
Subjects will undergo daily repetitive transcranial magnetic stimulation (rTMS), defined as Monday through Friday, for a total of 10 consecutive sessions.
rTMS will be applied using the NeuroStar TMS Therapy System through a figure-8 coil connected to a magnetic stimulator, which provides a biphasic pulse.
The coil is applied to the primary motor cortex, M1, contralateral to the painful side.
The optimal stimulus site, motor hot spot, will be determined according to visual detection of muscle twitches, and a resting motor threshold is defined as the minimal intensity necessary to induce at least one visible muscle twitch.
An rTMS session consists of 10 trains at 90% intensity of resting motor threshold (one train, 100 pulses at 10 Hz; intertrain interval, 50s).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline Visual Analogue Scale for Pain
Time Frame: Baseline and end of study participation, an average of 194 days
|
100 mm line scale that is subject administered to subjectively rate current pain symptoms.
The subject will be instructed to draw a single vertical line that best describes current state.
The total score ranges from 0-100 with higher numbers indicating worse outcomes.
The VAS will be administered at every subject visit.
|
Baseline and end of study participation, an average of 194 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Shona L Ray-Grififth, MD, University of Arkansas
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 (Estimate)
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
- 204737
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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