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Non-pharmacological Treatments in Migraine.

Primary Purpose

Migraine

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
dual task protocol: active exercises with concomitant cognitive training in executive functions
active exercise
cognitive task only
Sponsored by
University of Trieste
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine focused on measuring Migraine, Habituation, Sensitization, transcranial Magnetic stimulation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • diagnosis migraine (diagnostic criteria of ICDH3-beta)
  • Age over 18

Exclusion Criteria:

  • pregnancy
  • serious psychiatric pathologies
  • serious pathologies as traumas, cancers or infective pathologies
  • important surgery procedures during the last year
  • physiotherapy and other no pharmacological treatment for another pathology
  • less than 18 years of age;
  • presence of multiple migraine
  • presence of therapeutics changes linked to headache in the last 3 months
  • absence of pharmacological prophylaxis treatment in the last 3 months
  • no auditory or visual processing disorders

Sites / Locations

  • Manuela DeodatoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Dual task (active exercise and cognitive task)

active exercise only

Cognitive task trainig only

Arm Description

The dual task protocol is going to be in 15 one-hour sessions once a week in the headache free days. This protocol will be set up in the clinic of physiotherapy degree (University of Trieste in the Department of Medical, Surgical, and Health Sciences). The physical training tasks will be associated with concomitant cognitive tasks specifically relying on executive function. The goal is to engage the three core executive functions: inhibition (the ability to inhibit automated responses), working memory (the ability to hold, process, and manipulate information in mind) and shifting (the ability to change stimulus-response associations for performing an ongoing task). Patients will be exposed to different cognitive tasks during physical activity such as walking or running on the treadmill, indoor cycling and balance exercises. -

The active exercise only intervention is going to consist of aerobic and flexibility training with a targeted duration of 1 hour, twice per week for 3 months.

The Cognitive task training only engage the three core executive functions: inhibition (the ability to inhibit automated responses), working memory (the ability to hold, process, and manipulate information in mind) and shifting (the ability to change stimulus-response associations for performing an ongoing task).

Outcomes

Primary Outcome Measures

Values of Transcranial magnetic stimulation in migraine patients
Rest motor threshold in mV
Change from Baseline of the values of Transcranial magnetic stimulation in migraine patients at 3 months
Rest motor threshold in mV
Change from baseline of the value of Transcranial magnetic stimulation in migraine patients at 4 months
Rest motor threshold mV

Secondary Outcome Measures

Headache parameters Frequency of migraine
migraine days per month assessed with diary
Headache parameters Frequency of migraine
Change from baseline of migraine days per month assessed with diary at 3 months
Headache parameters frequency of migraine
Change migraine days per month assessed with diary at 4 months

Full Information

First Posted
May 23, 2022
Last Updated
October 27, 2022
Sponsor
University of Trieste
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1. Study Identification

Unique Protocol Identification Number
NCT05596058
Brief Title
Non-pharmacological Treatments in Migraine.
Official Title
Efficacy of a Non-pharmacological Treatments on Neurophysiological and Clinical Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
October 1, 2022 (Actual)
Study Completion Date
November 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Trieste

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Migraine may have an adverse effect on physical, cognitive, and psychosocial functioning. It causes major consequences for the quality of life of the sufferer and a major burden on the health care system. About the physiopathology, two opposing processes, depression (habituation) and facilitation (sensitization), determine the final behavioural outcome after a sequence of repetitive stimuli. Sensitization is a general behavioural response of augmentation to innocuous sensory and noxious stimuli. It has been associated with a dysfunction in descending pain inhibition. The nature or intensity of a painful event does not strongly relate to the development of chronic pain, but an individual's behavioural response to the event contributes to chronicity. Imaging data have identified that chronic pain may change the structure of the brain in response to environmental demands. It suggests that the brain of healthy control has a "healthy response" to frequent nociceptive input, such as "habituation", while chronic pain patients show a "maladaptive plasticity". Habituation is "a response decrement as a result of repeated stimulation". It is a phenomenon observed in the autonomic and behavioural component called the "orienting response" in humans. The orienting response is elicited when a novel stimulus is encountered, and it directs attention toward that stimulus. When the same stimulus is presented repeatedly occur habituation. Researchers have found a number of physiological mechanisms associated with Orienting response. Habituation of the orienting response is a simple form of learning and acts an attentional filtering mechanism that makes people able to select what is part of their present goal and adapt to environment. In this way only one channel of information to be processed, with the rest filtered out. Habituation depends on a memory process whereby the organism learns to associate goal irrelevant stimuli with a no-consequence response. Lack of Habituation during stimulus repetition is a functional property of the brain in people with migraine between attacks. Thalamo-cortical dysrhythmia and lack of H characterize migraineurs' brains. This abnormal information processing increases during the pain-free days, the vertex is just before the attack, and decreases in the ictal phase. Migraineurs are characterized by a generally increased sensitivity to visual (sensitivity to light), auditory (to sound), or somatic stimuli not only during the attack, but also outside of the attack. It was confirmed also by analysing motor cortex excitability. Aerobic exercises may be effective as pharmacological treatment in the management of migraine and focused attention task may help human subjects to better ignore irrelevant stimuli. The main aim of this study is to assess the efficacy of a non-pharmacological treatment, such as physical therapy, with a specific dual task protocol of active exercise with concomitant cognitive tasks, in relation to habituation (Transcranial magnetic stimulation) and sensitization (Algometer assessment) neurophysiological outcomes. The second aim is to assess these non-pharmacological treatments concerning to clinical outcomes (intensity of pain, duration of attacks and frequency of pain; neurophysiological test on executive functions).
Detailed Description
A Randomized Controlled Trial (RCT) will be conducted on three groups of patients with migraine. The project was approved by the institutional review board C.E.U.R. . Patients will be recruited and randomized by the Neurologic Clinic, Headache Centre (University of Trieste in the Department of Medical, Surgical, and Health Sciences), diagnosing Migraine after a neurologic visit (diagnostic criteria of ICDH3-beta). In the first enrollment visit (T0), the patients will be undergone anamnestic evaluation, neurological and general objective examination. The following criteria of exclusion are going to be respected: pregnancy; serious psychiatric pathologies, serious pathologies as traumas, cancers or infective pathologies, important surgery procedures during the last year; physiotherapy and other no pharmacological treatment for another pathology; less than 18 years of age; presence of multiple migraine; presence of therapeutics changes linked to headache in the last 3 months; absence of pharmacological prophylaxis treatment in the last 3 months; no auditory or visual processing disorders. While, the criteria of inclusion are going to be the following: diagnosis migraine (diagnostic criteria of ICDH3-beta); Age over 18. Patients are going to be given a diary for cephalic outcome: frequency (headache days a month), intensity and duration of attack. The paper diary is going to inserted into a specific database for subsequent data analysis. All patients are going to re-evaluated with the diary after one month (T1). The frequency is going to be between 15 days a month and 18 days a month. Transcranial magnetic Stimulation is going to be recorded.The Migraine disability assessment scale (MIDAS) will be performed. The MIDAS questionnaire consist of five questions aimed at assessing the impact of migraine on the patients' daily life in the 3 months prior to the study, in terms of absence from work or school, inability to carry out household chores, or take part in family, social, or leisure activities expressed in days. The final score was obtained by adding up the total number of days for each of the five questions. Simple randomization scheme 1:1:1 was used with excel and assign subjects into three groups respectively: 15 patients in physical-cognitive tasks groups, 15 patients in active exercise Only and 15 patients in Cognitive task only. All patient going to sign the informed consent. Patients will be allowed to take symptomatic medications in case of severe headache according to guidelines of the International Headache Society. Patients will be only asked to limit symptomatic medications consumption for a maximum twice per week in order to not affect the interpretation of data. Finally, after three months of treatment, the final visit will be performed (T2) with clinical re-evaluation of the patients and analysis of the cephalic parameters reported in the diary, the data of transcranial magnetic stimulation and the headache-related disability with MIDAS. All patients will be reexamined at 1 months follow up (T3) with the diary, Transcranial magnetic stimulation and MIDAS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
Migraine, Habituation, Sensitization, transcranial Magnetic stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
We are going to use a simple randomization scheme 1:1:1 with excel and assign subjects into three groups respectively: 15 patients in physical-cognitive tasks groups, 15 patients in active exercise Only and 15 patients in Cognitive training.
Masking
ParticipantOutcomes Assessor
Masking Description
Patients do not know other type of intervention; who have to do the assessment do not know the type of interventions
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dual task (active exercise and cognitive task)
Arm Type
Experimental
Arm Description
The dual task protocol is going to be in 15 one-hour sessions once a week in the headache free days. This protocol will be set up in the clinic of physiotherapy degree (University of Trieste in the Department of Medical, Surgical, and Health Sciences). The physical training tasks will be associated with concomitant cognitive tasks specifically relying on executive function. The goal is to engage the three core executive functions: inhibition (the ability to inhibit automated responses), working memory (the ability to hold, process, and manipulate information in mind) and shifting (the ability to change stimulus-response associations for performing an ongoing task). Patients will be exposed to different cognitive tasks during physical activity such as walking or running on the treadmill, indoor cycling and balance exercises. -
Arm Title
active exercise only
Arm Type
Active Comparator
Arm Description
The active exercise only intervention is going to consist of aerobic and flexibility training with a targeted duration of 1 hour, twice per week for 3 months.
Arm Title
Cognitive task trainig only
Arm Type
Active Comparator
Arm Description
The Cognitive task training only engage the three core executive functions: inhibition (the ability to inhibit automated responses), working memory (the ability to hold, process, and manipulate information in mind) and shifting (the ability to change stimulus-response associations for performing an ongoing task).
Intervention Type
Other
Intervention Name(s)
dual task protocol: active exercises with concomitant cognitive training in executive functions
Intervention Description
The active exercise tasks will be associated with concomitant cognitive tasks specifically relying on executive function. The goal is to engage the three core executive functions: inhibition (the ability to inhibit automated responses), working memory (the ability to hold, process, and manipulate information in mind) and shifting (the ability to change stimulus-response associations for performing an ongoing task). Patients will be exposed to different cognitive tasks during physical activity such as walking or running on the treadmill, indoor cycling and balance exercises.
Intervention Type
Other
Intervention Name(s)
active exercise
Intervention Description
Physical activity and motor task only
Intervention Type
Other
Intervention Name(s)
cognitive task only
Intervention Description
cognitive exercise in executive functions
Primary Outcome Measure Information:
Title
Values of Transcranial magnetic stimulation in migraine patients
Description
Rest motor threshold in mV
Time Frame
Before each treatment
Title
Change from Baseline of the values of Transcranial magnetic stimulation in migraine patients at 3 months
Description
Rest motor threshold in mV
Time Frame
after 3 months
Title
Change from baseline of the value of Transcranial magnetic stimulation in migraine patients at 4 months
Description
Rest motor threshold mV
Time Frame
after 4 months
Secondary Outcome Measure Information:
Title
Headache parameters Frequency of migraine
Description
migraine days per month assessed with diary
Time Frame
Before each treatment
Title
Headache parameters Frequency of migraine
Description
Change from baseline of migraine days per month assessed with diary at 3 months
Time Frame
after 3 months of each treatment
Title
Headache parameters frequency of migraine
Description
Change migraine days per month assessed with diary at 4 months
Time Frame
after 4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diagnosis migraine (diagnostic criteria of ICDH3-beta) Age over 18 Exclusion Criteria: pregnancy serious psychiatric pathologies serious pathologies as traumas, cancers or infective pathologies important surgery procedures during the last year physiotherapy and other no pharmacological treatment for another pathology less than 18 years of age; presence of multiple migraine presence of therapeutics changes linked to headache in the last 3 months absence of pharmacological prophylaxis treatment in the last 3 months no auditory or visual processing disorders
Facility Information:
Facility Name
Manuela Deodato
City
Trieste
State/Province
TS
ZIP/Postal Code
34148
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manuela Deodato
Phone
0403998565
Email
mdeodato@units.it

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Non-pharmacological Treatments in Migraine.

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