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

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Theta-Burst Stimulation
High frequency stimulation
Sponsored by
Institute of Mental Health Nottingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Transcranial Magnetic Stimulation, Neuronavigation, Magnetic Resonance Imaging

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Neuromodulation Unit, Nottinghamshire Healthcare NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Theta-Burst Stimulation

High Frequency stimulation

Arm Description

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 Transcranial Magnetic Stimulation using the standard protocol for depression, on left dorsolateral prefrontal cortex.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Mean change in Beck Depression Inventory scores

Full Information

First Posted
December 15, 2013
Last Updated
August 31, 2017
Sponsor
Institute of Mental Health Nottingham
Collaborators
Nottinghamshire Healthcare NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT02016456
Brief Title
TMS Treatment for Depression in the National Health Service
Acronym
TDEP
Official Title
An Evaluation of Transcranial Magnetic Stimulation in the National Health Service
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institute of Mental Health Nottingham
Collaborators
Nottinghamshire Healthcare NHS Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Transcranial Magnetic Stimulation, Neuronavigation, Magnetic Resonance Imaging

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Theta-Burst Stimulation
Arm Type
Experimental
Arm Description
Theta-Burst protocol for transcranial magnetic stimulation on dorsolateral prefrontal cortex (exact location to be determined using neuronavigation guided by Magnetic Resonance Imaging)
Arm Title
High Frequency stimulation
Arm Type
Active Comparator
Arm Description
High frequency Transcranial Magnetic Stimulation using the standard protocol for depression, on left dorsolateral prefrontal cortex.
Intervention Type
Device
Intervention Name(s)
Theta-Burst Stimulation
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
High frequency stimulation
Intervention Description
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 Outcome Measure Information:
Title
Proportion of responders defined as subjects with 50% reduction in the 17-item Hamilton Depression Scale Score
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Mean change in Beck Depression Inventory scores
Time Frame
4 weeks
Other Pre-specified Outcome Measures:
Title
Change in processing speed (using modified digit-symbol test) scores
Time Frame
4 weeks and 3 months
Title
Change in Clinical Global Impression scores
Time Frame
4 weeks and 3 months
Title
Change in Social and Occupational Functioning Assessment scores
Time Frame
4 weeks and 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sudheer Lankappa, MRCPsych
Organizational Affiliation
Nottinghamshire Healthcare NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neuromodulation Unit, Nottinghamshire Healthcare NHS Trust
City
Nottingham
State/Province
England
ZIP/Postal Code
NG2 7UH
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://www.nlm.nih.gov/medlineplus/depression.html
Description
Related Info

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