NCT02016456

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started Oct 2014

Typical duration for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 15, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 20, 2013

Completed
10 months until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

September 1, 2017

Status Verified

August 1, 2017

Enrollment Period

2.8 years

First QC Date

December 15, 2013

Last Update Submit

August 31, 2017

Conditions

Depression

Keywords

Transcranial Magnetic StimulationNeuronavigationMagnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

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

    4 weeks

Secondary Outcomes (1)

  • Mean change in Beck Depression Inventory scores

    4 weeks

Other Outcomes (3)

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

    4 weeks and 3 months

  • Change in Clinical Global Impression scores

    4 weeks and 3 months

  • Change in Social and Occupational Functioning Assessment scores

    4 weeks and 3 months

Study Arms (2)

Theta-Burst Stimulation

EXPERIMENTAL

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

High Frequency stimulation

ACTIVE COMPARATOR

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

Device: High frequency stimulation

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.

Theta-Burst Stimulation
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

High Frequency stimulation

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neuromodulation Unit, Nottinghamshire Healthcare NHS Trust

Nottingham, England, NG2 7UH, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Sudheer Lankappa, MRCPsych

    Nottinghamshire Healthcare NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Psychiatrist

Study Record Dates

First Submitted

December 15, 2013

First Posted

December 20, 2013

Study Start

October 1, 2014

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

September 1, 2017

Record last verified: 2017-08

Locations

GB(1)