Trial document




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  DRKS00029024

Trial Description

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Title

Delving in the behavioural and neural correlates of pain perception using a therapy combining mindfulness meditation and transcranial direct current stimulation for the treatment of fibromyalgia syndrome.

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Trial Acronym

Med_tDCS_Fibro

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URL of the Trial

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Brief Summary in Lay Language

Mindfulness meditation and non-invasive transcranial electric stimulation through the skull are two promising non-pharmacological therapies in managing pain in fibromyalgia syndrome. In this clinical study, we are testing the therapeutic effects of combining these two techniques in patients with fibromyalgia syndrome, as well as to understand the underlying mechanisms of this novel therapy. The treatment will include 10 daily 20-minute sessions of very low transcranial electric stimulation, with the positive electrode placed on the scalp over the brain area involved in movement. All participants will receive one month of training in mindfulness before the delivery of the combined therapy. Pain intensity will be rated twice daily by the participants throughout the study in a pain diary and quality of life will be assessed. In addition, we will also measure the excitability of the brain using non-invasive transcranial magnetic stimulation and the severity of fibromyalgia-associated symptoms using self-reported questionnaires, among others. Measurement visits will take place before and after the mindfulness training as well as immediately after and four weeks following the combined therapy.

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Brief Summary in Scientific Language

Over the years, combining different non-pharmacological interventions in the treatment of fibromyalgia syndrome has been shown to be a promising therapeutic direction. In this double-blinded, randomized and sham-controlled clinical study, we aim to i) study the analgesic effects of pairing mindfulness meditation and anodal transcranial direct current stimulation in patients with fibromyalgia syndrome, together with understanding potential mechanisms using transcranial magnetic stimulation, ii) investigate the interaction between autonomic nervous system and perceived pain and iii) find the best single or combination of prognostic biomarkers in order to define the possible efficacy of the therapy. The active therapeutic intervention will include 10 daily 20-minute sessions of 2 mA transcranial direct current stimulation, with anodal stimulation at the left primary motor cortex while the participants are meditation. All participants will receive one month of training in mindfulness before the delivery of the combined therapy. The primary outcomes are pain intensity measured on a numerical rating scale throughout the study and quality of life assessed using the Fibromyalgia Impact Questionnaire. Secondary outcomes include assessment of associated disease symptoms, excitability of the motor cortex and brain-heart interactions. Measurements will be taken at baseline, following the mindfulness training as well as immediately after and four weeks following the combined therapy.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00029024
  •   2022/05/31
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  •   yes
  •   Approved
  •   9/1/22, Ethik-Kommission der Medizinischen Fakultät der Georg-August-Universität Göttingen
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Secondary IDs

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Health Condition or Problem studied

  •   M79.7 -  Fibromyalgia
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Interventions/Observational Groups

  •   Experimental: Anodal transcranial direct current stimulation of the left primary motor cortex (10 daily 20-min sessions, 2 mA) paired with mindfulness meditation. Prior to the combined intervention, all participants will receive a one-month training in mindfulness as training. The combined therapy can either be clinic- or home-based.
  •   Sham comparator: sham transcranial direct current stimulation combined with mindfulness meditation in participants trained in mindfulness (one-month mindfulness training). The combined intervention can either be clinic- or home-based.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist
  •   Placebo
  •   Treatment
  •   Parallel
  •   II
  •   N/A
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Primary Outcome

1. Numerical Rating Scale (NRS) for pain intensity (Time frame: 14 weeks of the study).
Participants will rate their pain level in a pain diary, twice daily, using a 10 cm visual analogue scale (Total score: 0-10; 0= no pain, 10 = worst imaginable pain). Higher scores mean a worse outcome.

2. Quality of life (Time points: baseline, post mindfulness training, immediately after the last stimulation session of the bimodal therapy, one month after last stimulation)
Participants will fill in the Fibromyalgia Impact Questionnaire.


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Secondary Outcome

1. Cortical excitability of the left primary motor cortex using transcranial magnetic stimulation (TMS).
- Resting motor threshold of the right first dorsal interosseous muscle.
- Recruitment curves with intensity of single TMS pulses at 90%, 100%, 110%, 120%, 130% and 140% of the resting motor threshold.
- Intracortical facilitation and inhibition using paired pulse TMS.
2. Interaction between brain and heart.
- Power analysis of resting state 64-channel EEG
- Heart rate and heart rate variability using resting state 3-channel ECG
- Heart evoked potential, a marker of cardiac interoception, measured using concurrent EEG and ECG
3. Quality of life using the Fibromyalgia Impact Questionnaire.
4. Mood using the Positive and Negative Affect Schedule.
5. Depression, anxiety and stress levels using the Depression, Anxiety and Stress Scale.
6. Sleep quality assessed with the Pittsburg Sleep Quality Index.
7. Mindfulness level using the Five Facet Mindfulness Questionnaire.
8. Self-management ability using the Selbststeuerungs-Inventar (SSI-K3). This will be used to test any association between responders to the treatment and self-management ability.
9. Word finding ability using the Regensburger word fluency test.

All measures will take place at baseline, after the mindfulness training, immediately after the last stimulation session of the bimodal therapy and one month following the last stimulation session.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2022/05/30
  •   80
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   30   Years
  •   75   Years
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Additional Inclusion Criteria

1. Stable disease for at least 6 months prior to participation
2. No new treatment approaches over the preceding 3 months
3.Stable allowed fibromyalgia related medications (see below) for ≥ 4 weeks prior to the
study. List of allowed medications:
-Intake of NSAIDs and coxibs as required (bei Bedarf), but participants must not take it 24
hours prior to study visits.
- Commonly used antidepressants for FMS will be allowed.
-Low dose (<25 mg THC content/day) of medical oromucosal cannabinoid therapy (e.g.
dronabinol, nabiximols, extracts). The participant has to refrain from taking it up to 24 hours
prior to study visits.
-Corticosteroids for comorbid conditions if the dose was constant within the last four
weeks before baseline and if the dose will likely remain constant for the duration of this trial.

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Exclusion Criteria

1. Treatment with any of the following medications:
- Strong opioids, or taking more than three medications for fibromyalgia symptom relief.
- Carbamazepine, benzodiazepines, phenytoin, gabapentin, pregabalin; calcium channel
antagonists (e.g. flunarizine), NMDA receptor antagonists (e.g. dextromethorphan, memantine),
anticholinergics.
- Therapeutic local anesthetic infiltration of the spinal column within the last 4 weeks
before baseline and/or planned during the trial period.
- Topically administered medication with influence on the study target during the study
Inhaled or smoked cannabinoids for medical use.
2. presence of any major, acute or unstable medical, neurological or psychiatric disorder,
diagnosis of severe or uncontrolled comorbid rheumatic disease, non-treated tumors, ongoing
chemo- or radiation therapy, clotting disorders or anticoagulant therapy
3. Chronic migraine (at least 15 headache days/months, with at least 8 fulfilling criteria for
migraine
4. Alcohol/drug addiction, abuse of any substance (except nicotine and caffeine) currently
and/or within the last 12 months prior to randomization
5. Pregnancy or breastfeeding
6. History of unexplained or repeated loss of consciousness
7. Implanted metallic devices in head, neck or chest
8. Participation in another scientific or clinical study within 12 weeks prior to study
inclusion
9. History of major surgery in the last three months
10. Planned or ongoing pension proceedings
11. Any planned surgery or inpatient treatment which might conflict with or influence the
participation or results of the study.
12.History or suspicion of unreliability, poor co-operation or non-compliance with medical
treatment
13. Mental condition, legal incapacity, and/or other circumstances rendering the patient
unable to understand the nature, scope and possible consequences of the study
14. Acupuncture or chiropractic manipulations within the last 4 weeks before baseline
and/or during the trial.
15.Formal meditation practice of high intensity

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Addresses

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    • Universitätsmedizin Göttingen
    • Robert-Koch-Straße 40
    • 37075  Göttingen
    • Germany
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    • Klinik für Neurologie, Universitätsmedizin Göttingen
    • Ms.  Prof. Dr. rer. nat.  Andrea  Antal 
    • Robert-Koch-Strasse 40
    • 37075  Göttingen
    • Germany
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    •   +49 551 39 8461
    •   +49 551 39 8126
    •   aantal at gwdg.de
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    • Klinik für Neurologie, Universitätsmedizin Göttingen
    • Mr.  MSc.   Perianen  Ramasawmy 
    • Robert Koch Straße 40
    • 37075  Göttingen
    • Germany
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    • Klinik für Neurologie, Universitätsmedizin Göttingen
    • Ms.  Prof. Dr. rer. nat.  Andrea  Antal 
    • Robert-Koch-Strasse 40
    • 37075  Goettingen
    • Germany
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    •   +49-551-39 8461
    •   +49-551-39 8126
    •   AAntal at gwdg.de
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Sources of Monetary or Material Support

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    • Universitätsmedizin Göttingen
    • Robert-Koch-Straße 40
    • 37075  Göttingen
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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