TMS Treatment for Depression in the National Health Service (TDEP)

August 31, 2017 updated by: Sudheer Lankappa, Institute of Mental Health Nottingham

An Evaluation of Transcranial Magnetic Stimulation 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • England
      • Nottingham, England, United Kingdom, NG2 7UH
        • Neuromodulation Unit, Nottinghamshire Healthcare NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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)
Device: Theta-Burst Stimulation
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.
Active Comparator: High Frequency stimulation
High frequency Transcranial Magnetic Stimulation using the standard protocol for depression, on left dorsolateral prefrontal cortex.
Device: High frequency stimulation
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of responders defined as subjects with 50% reduction in the 17-item Hamilton Depression Scale Score
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean change in Beck Depression Inventory scores
Time Frame: 4 weeks
4 weeks

Other Outcome Measures

Outcome Measure
Time Frame
Change in processing speed (using modified digit-symbol test) scores
Time Frame: 4 weeks and 3 months
4 weeks and 3 months
Change in Clinical Global Impression scores
Time Frame: 4 weeks and 3 months
4 weeks and 3 months
Change in Social and Occupational Functioning Assessment scores
Time Frame: 4 weeks and 3 months
4 weeks and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Mental Health Nottingham

Collaborators

Nottinghamshire Healthcare NHS Trust

Investigators

  • Principal Investigator: Sudheer Lankappa, MRCPsych, Nottinghamshire Healthcare Nhs Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

December 15, 2013

First Submitted That Met QC Criteria

December 15, 2013

First Posted (Estimate)

December 20, 2013

Study Record Updates

Last Update Posted (Actual)

September 1, 2017

Last Update Submitted That Met QC Criteria

August 31, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMH/021213

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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