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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02521480
Other study ID # 0615.11f
Secondary ID
Status Withdrawn
Phase N/A
First received August 10, 2015
Last updated March 7, 2016
Start date July 2015
Est. completion date December 2016

Study information

Verified date March 2016
Source East Tennessee State University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

To determine whether real TMS is more effective than sham TMS in reducing pain following surgery


Description:

To determine the amount of opiate and pain medication administered in the week following surgery. Subjects will receive an identical pain control regimen. Participants will undergo TMS motor threshold assessment at the ETSU Innovation Lab prior to the planned surgery. At this appointment a baseline Beck Depression Inventory (BDI), Center for Epidemiological Studies 10-item Depression scale (CES-D) and visual analog scale (VAS) ratings of pain and mood will be obtained.VAS ratings will also be done each evening over the following week. One day after surgery, the subject will return to the Innovation lab for TMS. A total of 22 subjects will be recruited for the study. At the return visit, 11 will receive 40 minutes of 10 Hz repetitive TMS at 120% of rMT (4-second stimulation trains with 26-second interstimulus intervals). The other 11 participants will receive sham treatment under identical settings. Participants, medical staff providing clinical care to patients and raters will not know whether participants receive real or sham TMS. Patients will keep a log of pain medications used over the following week in addition to the VAS ratings. Follow-up will occur one week after the TMS therapy. The subject will turn in logs and repeat BDI and CES-D scales.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 2016
Est. primary completion date July 2016
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria: Dental fillings, implants, and bridge work are permitted. -

Exclusion Criteria: Metal objects within 30 cm of the brain. These include cochlear implants, stents, vagus nerve stimulators, heart devices, bullet fragments, or jewelry. Monitors, earrings, hearing aids, eyeglasses, jewelry, hair barrettes, cell phones, and digital sound recording device players will be removed. Actively suicidal. Older than 70 years. Seizures, strokes, dementia, or movement disorders. Pregnant or nursing. Permanent makeup with metal ink. Medication known to increase risk of seizures.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Active Transcranial Magnetic Stimulation
TMS is a non-invasive treatment. During TMS treatment, a coil, which creates a magnetic field, will be placed on the left prefrontal area of the head. Active TMS will stimulate for 4 seconds, pause for 26 seconds, and repeat this for approximately 40 minutes. There will be a total of 3000 pulses during treatment. We expect TMS to decrease pain and depression. In order to find out if this is true, we will compare real TMS with sham (inactive) TMS.This will allow us to decide if active TMS is successful because of electrical stimulation, or because of the support, concern, and understanding of the research team.
Sham Transcranial Magnetic Stimulation
Inactive treatment (simulation of active TMS)

Locations

Country Name City State
United States ETSU Dept. of Psychiatry Johnson City Tennessee

Sponsors (2)

Lead Sponsor Collaborator
East Tennessee State University Neuronetics

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Daily and total mg of opiate pain medication and any other over the counter alternate pain medication. One year No
Secondary Changes in Visual Analog Scales daily for mood and pain as well as an initial and final Beck Depression Inventory and Center for Epidemiological Studies 10-item Depression Scale One year No
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