Neuropathic Pain in Pregnancy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02608463|
Recruitment Status : Active, not recruiting
First Posted : November 18, 2015
Last Update Posted : April 10, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pain Pregnancy||Device: Transcranial Magnetic Stimulation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Neuropathic Pain in Pregnancy|
|Actual Study Start Date :||January 1, 2016|
|Estimated Primary Completion Date :||October 2018|
|Estimated Study Completion Date :||October 2018|
Experimental: Neuropathic Pain
Subjects will complete the painDETECT Questionnaire at study entry and be assigned to this group with a score ≥13. They will receive be invited to participate in repetitive transcranial magnetic stimulation (rTMS).
Device: Transcranial Magnetic Stimulation
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).
No Intervention: Non-neuropathic Pain
Subjects will complete the painDETECT Questionnaire at study entry and be assigned to this group with a score on the 1≥score≤12 on the PDQ. They will receive no study intervention.
No Intervention: Control
Subjects will complete the painDETECT Questionnaire at study entry and be assigned to this group with a score = 0 on the PDQ. They will receive no study intervention.
- Change from Baseline Visual Analogue Scale for Pain [ Time Frame: Within approximately 40 weeks (pregnancy) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02608463
|United States, Arkansas|
|University of Arkansas For Medical Sciences|
|Little Rock, Arkansas, United States, 72205|
|Principal Investigator:||Shona L Ray-Grififth, MD||University of Arkansas|