TMS Treatment for Depression in the National Health Service

Not Applicable

Completed

• Conditions: Depression
• Interventions: Device: Theta-Burst Stimulation; Device: High frequency stimulation

• Registration Number: NCT02016456
• Lead Sponsor: Institute of Mental Health Nottingham

Brief Summary

This research programme purports to test the effectiveness of two Transcranial Magnetic Stimulation (TMS) protocols (Repetitive high frequency protocol and Theta Burst protocol) in reducing the symptoms of depression. The study also uses Magnetic Resonance Imaging (MRI) scans to improve the localization of TMS targets.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-12-15
• Study First Submitted QC: 2013-12-15
• Study First Posted: 2013-12-20
• Study Start: 2014-10
• Status Verified: 2017-08
• Primary Completion: 2017-08
• Study Completion: 2017-08
• Last Update Submitted: 2017-08-31
• Last Update Posted: 2017-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

• Diagnosis of depressive disorder (DSM-IV)
• Diagnosis of treatment resistance (at least stage 1 as defined by Thase & Rush, 1997 for depression)
• Female or male between 18 and 70 years

Exclusion Criteria

• History of Bipolar disorder
• Clinically relevant neurological comorbidity such as brain neoplasm, cerebral vascular events, epilepsy, neurodegenerative disorders, prior brain surgery
• Metal objects in and around body that cannot be removed
• Pregnancy
• Cardiac pacemaker or implanted medication pump
• Major unstable medical illness
• Change in prescribed medication in the 2 weeks preceding the start of TMS trial
• Current alcohol/stimulant dependence with propensity for toxic/withdrawal seizures

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Theta-Burst Stimulation	Theta-Burst Stimulation	Theta-Burst protocol for transcranial magnetic stimulation on dorsolateral prefrontal cortex (exact location to be determined using neuronavigation guided by Magnetic Resonance Imaging)
High Frequency stimulation	High frequency stimulation	High frequency Transcranial Magnetic Stimulation using the standard protocol for depression, on left dorsolateral prefrontal cortex.

Primary Outcome Measures

Name	Time	Method
Proportion of responders defined as subjects with 50% reduction in the 17-item Hamilton Depression Scale Score	4 weeks

Secondary Outcome Measures

Name	Time	Method
Mean change in Beck Depression Inventory scores	4 weeks

Trial Locations

Locations (1)

Neuromodulation Unit, Nottinghamshire Healthcare NHS Trust; 🇬🇧 Nottingham, England, United Kingdom