Neuropathic Pain in Pregnancy

NCT02608463 | Completed Results DMC FDA Device

• 1 other identifier: 204737
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This will be the first study to investigate the use of rTMS in the treatment of neuropathic pain in pregnancy. This study will enroll 60 pregnant subjects, age 18-45. All participants will receive treatment as usual. Subjects diagnosed with neuropathic pain will be offered rTMS as a treatment option.

Conditions

Pain; Pregnancy

Keywords

neuropathic pain; pregnancy

Outcome Measures

Primary Outcomes (1)

• Change From Baseline Visual Analogue Scale for Pain

  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

Study Arms (4)

Part A - Neuropathic Pain

OTHER

Subjects with a score of ≥ 13 on the painDETECT Questionnaire (PDQ) will be assigned to the Neuropathic Pain group.

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

Part A - Non-Neuropathic Pain

OTHER

Subjects with a score of ≥ 1 or ≤ 12 on the painDETECT Questionnaire (PDQ) will be assigned to the Non-Neuropathic Pain group.

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

Part A - Control

OTHER

Subjects with a score of score = 0 on the painDETECT Questionnaire (PDQ) will be assigned to the Control group.

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

Part B - rTMS

EXPERIMENTAL

Subjects from the Neuropathic Pain group will be invited to participate in the Part B rTMS group to receive repetitive transcranial magnetic stimulation (rTMS).

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

Interventions

painDETECT Questionnaire BEHAVIORAL

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.

Also known as: PDQ

Part A - Control; Part A - Neuropathic Pain; Part A - Non-Neuropathic Pain

Pain Catastrophizing Scale BEHAVIORAL

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.

Also known as: PCS

Part A - Control; Part A - Neuropathic Pain; Part A - Non-Neuropathic Pain

Pain Intensity Scale, Pain Interference Scale, Pain Behavior Scale BEHAVIORAL

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.

Also known as: Pain Measures

Part A - Control; Part A - Neuropathic Pain; Part A - Non-Neuropathic Pain

Beck Depression Inventory BEHAVIORAL

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).

Also known as: BDI

Part A - Control; Part A - Neuropathic Pain; Part A - Non-Neuropathic Pain; Part B - rTMS

Visual Analogue Scale BEHAVIORAL

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.

Also known as: VAS

Part A - Control; Part A - Neuropathic Pain; Part A - Non-Neuropathic Pain; Part B - rTMS

Patient's Global Impression of Change Scale & Clinical Global Impression-Global Improvement Scale BEHAVIORAL

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.

Also known as: PGIC & CGI-I

Part A - Control; Part A - Neuropathic Pain; Part A - Non-Neuropathic Pain; Part B - rTMS

Transcranial Magnetic Stimulation DEVICE

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).

Also known as: NeuroStar® TMS

Part B - rTMS

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• age 18-45 years old,
• ability to give informed consent,
• viable pregnancy, and
• enrollment prior or equal to 24 weeks gestation

You may not qualify if:

• Active or history of substance use disorder within the past year
• Non-English speaking
• Part B
• 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
• Current or past history of a seizure disorder (e.g., epilepsy)
• Current history of preeclampsia
• Current or history of brain lesions (e.g., aneurysm)

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas For Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

Pain; Neuralgia

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Limitations and Caveats

Early termination due to inability to enroll pregnant subjects into the TMS intervention portion (Part B) of the study.

Results Point of Contact

• Title: Dr. Shona Ray-Griffith
• Organization: University of Arkansas for Medical Sciences

slray@uams.edu

501-526-8428

Study Officials

• Shona L Ray-Grififth, MD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All subjects will participate in Part A, receive standard of care and complete the painDETECT Questionnaire (PDQ) to be assigned to 1 of 3 groups based on the PDQ score. Subjects in Part A will complete the following at study entry and each study visit: the Beck Depression Inventory (BDI), Visual Analogue Scale (VAS), Pain Catastrophizing Scale (PCS), and measures of pain intensity, interference, behavior. At each visit after study entry, subjects will complete the Patients' Global Impression of Change scale (PGIC); clinicians will complete the Clinical Global Impression-Global Improvement scale (CGI-I). Subjects in Part B will receive rTMS and be followed daily until day 29 after last rTMS session. For each session, subjects will complete a VAS prior, immediately after, and 60 minutes post, day 22 \& day 29; a BDI on Days 1, 5, 12, 22, \& 29; on days 5, 12, 22, \& 29 subjects will complete the PGIC; clinicians will complete the CGI-I.

Study Record Dates

• First Submitted: November 13, 2015
• First Posted: November 18, 2015
• Study Start: January 1, 2016
• Primary Completion: April 19, 2019
• Study Completion: April 19, 2019
• Last Updated: June 23, 2021
• Results First Posted: September 2, 2020

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)