Epilepsy Clinical Trials

Find Epilepsy Clinical Trials Near You

High-Density EEG-MEG-wearable EEG: Comparison of Quantitative Electroencephalographic Indicators as Neurophysiological Markers of Effectiveness of Mindfulness Therapy in Addition to Standard Treatment in Patients With High-frequency Episodic Migraine

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
SUMMARY

Recent studies suggest that Mindfulness may be an effective treatment for migraine, reducing the frequency of attacks, depression, anxiety and improving quality of life. However, the pathophysiological mechanisms underlying the effectiveness are not yet fully known. The identification of neurophysiological markers may help to better understand the mechanisms on which Mindfulness acts in migraine sufferers and to develop increasingly targeted and personalized Mindfulness interventions to optimize migraine treatment. The main objective of the study is to identify neurophysiological indicators of effectiveness of Mindfulness treatment in patients with migraine without high-frequency aura with clinically available devices (MEG and hdEEG). Another goal is to recognize the indicators also in the signal acquired with wearable devices in home use (wEEG). Finally, another goal will be to study the relationship between the identified neurophysiological markers and the change in neuropsychological test scores.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• Adult patients will be included who fulfil the ICHD-3 criteria \[8\] for HFEM, code 1.3-Chronic Migraine (characteristics similar to CM but with a frequency of 8-14 migraine days per month) with stable therapy in the 3 months prior to the start of Mindfulness treatment. If the therapy is changed during the screening visit, the patient will wait 3 months before starting Mindfulness treatment.

Locations
Other Locations
Italy
Fondazione IRCCS Istituto Neurologico C. Besta
RECRUITING
Milan
Contact Information
Primary
Paola Lanteri, MD
paola.lanteri@istituto-besta.it
02.2394.2538
Backup
Elisa Visani, ENG
elisa.visani@istituto-besta.it
02.2394.2538
Time Frame
Start Date: 2024-04-23
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 40
Treatments
Group Mindfulness treatment
group undergoing 8 weeks of Mindfulness treatment and unchanged drug therapy
Group Standard of care
group re-evaluated after 8 weeks without any additional intervention and with unchanged drug therapy.
Related Therapeutic Areas
Sponsors
Leads: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

This content was sourced from clinicaltrials.gov