A double-blind randomised sham-controlled trial of prefrontal Theta Burst Stimulation for fibromyalgia

Investigators

Dr Bernadette Fitzgibbon | NHMRC Research Fellow and Head of Pain and Affect Neuroscience Unit

Professor Paul Fitzgerald | Deputy Director, Monash Alfred Psychiatry Research Centre

A/Prof Kate Hoy | Associate Professor (Research) and Head, Cognitive Therapeutics Group, Monash Alfred Psychiatry Research Centre

Ms Laura Knox | Study Coordinator, Monash Alfred Psychiatry Research Centre

The Study

This study aims to conduct a double-blind, randomized, sham-controlled proof of principle trial to establish the efficacy of Theta Burst Stimulation (TBS)  treatment  in  fibromyalgia .

Fibromyalgia and related disorders present a substantial health problem, with current treatments limited in their efficacy and associated with a number of side effects.

This study will explore for the first time in fibromyalgia a novel non-pharmaceutical  intervention , TBS; a non-invasive brain stimulation method. TBS is a powerful new  alternative  to standard non-invasive brain stimulation methods as it can be applied in a much more time efficient manner and may result in greater  clinical  benefit.

If successful, the application of this method for fibromyalgia may be applicable to related disorders such as  chronic  fatigue  syndrome.

Who can participate in the study?

You may be eligible to participate if;

you have a current diagnosis of fibromyalgia
you have had no increase or initiation of new medication therapy in the four weeks prior to study screen
you're aged between 18 and 75
you have no contraindications for TBS treatment

What's involved

Participation in this trial involves daily (Mon-Fri) 30-minute treatments for an initial two weeks and 30-minute treatments on three days in the second block of two weeks.

Participants will be randomised into one of two treatment groups (sham versus  active  treatment).

Participants will be asked to complete a battery of questionnaires at several points throughout the trial and at the one month follow-up point. Participants will also undergo TMS-EEG at baseline, endpoint and at the one month follow-up.

TMS-EEG is a painless procedure involving the placement of electrodes on the head to record the brain's electrical activity and functioning during a single pulse of transcranial magnetic stimulation (TMS).

Participants will attend treatments at the Monash Alfred Psychiatry Research Centre (MAPrc) located at Level 4, 607 St Kilda Road, Melbourne.

Participants will be required to attend daily for two weeks and three days per week in a second block of two weeks.

Participants will also be asked to attend a baseline appointment in the week before they commence treatment and a follow-up appointment one month post treatment.

How long will participants be actively involved in the study?

Two months. One month of the treatment course and a follow-up assessment one month post-treatment.

Closing Date
 
1 April 2020

Ethics and Funding

This study has been approved by Alfred Health Ethics Committee (project number 33-17). This research is funded by The Mason Foundation - National Medical Program.

Contact Information 

To express your interest in participating in this study please contact:
Ms Laura Knox
Study Coordinator, Monash Alfred Psychiatry Research Centre, The Alfred
Telephone: 03 9076 9897
Email: laura.knox@monash.edu