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Completed

NCT Number: NCT02016456

TMS Treatment for Depression in the National Health Service

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Neuromodulation Unit, Nottinghamshire Healthcare NHS Trust

Nottingham, England, NG2 7UH, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Theta-Burst Stimulation

Device

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 stimulation

Device

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

Primary outcomes

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

    Time frame: 4 weeks

Secondary outcomes

  1. Mean change in Beck Depression Inventory scores

    Time frame: 4 weeks

Other outcomes

  1. Change in processing speed (using modified digit-symbol test) scores

    Time frame: 4 weeks and 3 months

  2. Change in Clinical Global Impression scores

    Time frame: 4 weeks and 3 months

  3. Change in Social and Occupational Functioning Assessment scores

    Time frame: 4 weeks and 3 months

Sponsors and collaborators

Lead sponsor

Institute of Mental Health Nottingham

Other

Collaborators

  • Nottinghamshire Healthcare NHS Trust

Registry information

Official study title

An Evaluation of Transcranial Magnetic Stimulation in the National Health Service

Acronym: TDEP

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Dec 20, 2013
Registry last updated
Sep 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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