TMS Treatment for Depression in the National Health Service

N/ACompletedNCT02016456

Institute of Mental Health Nottingham29 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Depression

Interventions

Theta-Burst StimulationDEVICE

At 80% motor threshold determined using single pulse stimuli. Depending on the hemisphere determined by connectivity analysis and neuronavigation in each individual, either continuous (left prefrontal) or intermittent (right prefrontal) train of pulses will be delivered.

High frequency stimulationDEVICE

Left prefrontal stimulation. 120% motor threshold with a pulse sequence of 10 Hz for 4 seconds, followed by a 26 second quiet period. Treatment will last for a total of 37.5 minutes this is a total of 3,000 pulses

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Neuromodulation Unit, Nottinghamshire Healthcare NHS Trust

Nottingham, England, United Kingdom

Outcomes

Primary Outcomes

Proportion of responders defined as subjects with 50% reduction in the 17-item Hamilton Depression Scale Score

Time frame: 4 weeks

Secondary Outcomes

Mean change in Beck Depression Inventory scores

Time frame: 4 weeks

Data from ClinicalTrials.gov

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