NCT03984201

Accelerated Theta Burst in Chronic Pain: A Biomarker Study

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates an accelerated schedule of theta-burst stimulation using a transcranial magnetic stimulation device for chronic pain. In this double blind, randomized control study, participants will be randomized to the treatment group to receive accelerated theta-burst stimulation or to a control group. All participants will be offered the open-label, active treatment 4 week prior to completing the initial 5 days of treatment.

Detailed description

Repetitive transcranial magnetic stimulation (rTMS) is an established technology as therapy for treatment-resistant depression and has been utilized to treat persons suffering from chronic pain. The approved method for treatment is 10Hz stimulation for 40 min over the left dorsolateral prefrontal cortex (L-DLPFC). This methodology has been very successful in real world situations. The limitations of this approach include the duration of the treatment (approximately 40 minutes per treatment session). Recently, researchers have aggressively pursued modifying the treatment parameters to reduce treatment times with some preliminary success. This study intends to further modify the parameters to create a more rapid form of the treatment and look at the change in neuroimaging biomarkers.

Conditions

• Chronic Pain

Interventions

Type	Name	Description
DEVICE	Intermittent Theta Burst Stimulation (iTBS)	Participants will receive active or sham transcranial magnetic stimulation delivered to the L-DLPFC.

Timeline

• Start date: 2023-06-01
• Primary completion: 2024-08-01
• Completion: 2024-08-01
• First posted: 2019-06-12
• Last updated: 2024-12-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study