TMS Treatment for Depression in the National Health Service

NCT ID: NCT02016456

Last Updated: 2017-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2017-08-31

Brief Summary

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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

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Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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)

Group Type EXPERIMENTAL

Theta-Burst Stimulation

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

High frequency stimulation

Intervention Type 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

Interventions

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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.

Intervention Type 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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nottinghamshire Healthcare NHS Trust

OTHER_GOV

Sponsor Role collaborator

Institute of Mental Health Nottingham

OTHER

Sponsor Role lead

Responsible Party

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Sudheer Lankappa

Consultant Psychiatrist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sudheer Lankappa, MRCPsych

Role: PRINCIPAL_INVESTIGATOR

Nottinghamshire Healthcare NHS Trust

Locations

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Neuromodulation Unit, Nottinghamshire Healthcare NHS Trust

Nottingham, England, United Kingdom

Site Status

Countries

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United Kingdom

Related Links

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Other Identifiers

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AMH/021213

Identifier Type: -

Identifier Source: org_study_id

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