MigraineNCT05596058
Non-pharmacological Treatments in Migraine.
A study testing dual task protocol: active exercises with concomitant cognitive training in executive functions, active exercise and cognitive task only in people with Migraine, run by University of Trieste at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine
- What is being tested?
- dual task protocol: active exercises with concomitant cognitive training in executive functions, active exercise and cognitive task only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2022to 1 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis migraine (diagnostic criteria of ICDH3-beta)
- Age over 18
Who cannot join
- 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;
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of a Non-pharmacological Treatments on Neurophysiological and Clinical Outcomes
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.
Read more
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).
Read the 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.
- Conditions
- Migraine
- Being tested
- dual task protocol: active exercises with concomitant cognitive training in executive functions, active exercise, cognitive task only
- Keywords
- Migraine, Habituation, Sensitization, transcranial Magnetic stimulation
- Medical subject headings
- Migraine Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dual task protocol: active exercises with concomitant cognitive training in executive functionsOther
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.
active exerciseOther
Physical activity and motor task only
cognitive task onlyOther
cognitive exercise in executive functions
| Study group | Role | What they receive |
|---|---|---|
| Dual task (active exercise and cognitive task) | Experimental | 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.
- Receives: Other: dual task protocol: active exercises with concomitant cognitive training in executive functions |
| active exercise only | Active comparator | 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. Receives: Other: active exercise |
| Cognitive task trainig only | Active comparator | 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). Receives: Other: cognitive task only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Values of Transcranial magnetic stimulation in migraine patients
Rest motor threshold in mV
Measured: Before each treatment
Change from Baseline of the values of Transcranial magnetic stimulation in migraine patients at 3 months
Rest motor threshold in mV
Measured: 3 months
Change from baseline of the value of Transcranial magnetic stimulation in migraine patients at 4 months
Rest motor threshold mV
Measured: 4 months
Secondary outcomes (6)
Headache parameters and MIDAS
migraine days per month assessed with diary
Measured: Before each treatment
Headache parameters and MIDAS
Change from baseline of migraine days per month assessed with diary at 3 months
Measured: 3 months of each treatment
Headache parameters and MIDAS
Change migraine days per month assessed with diary at 4 months
Measured: 4 months
Algometer Assessment
Change pressure pain threshold in 6 muscles
Measured: Before each treatment
Algometer Assessment
change pressure pain threshold in 6 muscles
Measured: 3 months of each treatment
Algometer Assessment
change pressure pain threshold in 6 muscles
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start1 Jun 2022
- Primary completion1 Oct 2022
- Study completion1 Nov 2023
Why it stopped: Due to the unavailability of the subjects who gave the consent to participate to the study protocol
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Trieste
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manuela Deodato, University of Trieste
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05596058
- Sponsor's protocol ID
- 080_2020
- Status last verified
- Jan 2024
- First submitted
- 23 May 2022
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Non-pharmacological Treatments on Neurophysiological and Clinical Outcomes
- ClinicalTrials.gov ID
- NCT05596058
- Acronym / sponsor ID
- 080_2020
- Conditions
- Migraine
- Keywords
- Migraine, Habituation, Sensitization, transcranial Magnetic stimulation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to the unavailability of the subjects who gave the consent to participate to the study protocol
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of TriesteUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 27 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Dual task (active exercise and cognitive task) | Experimental | Other: dual task protocol: active exercises with concomitant cognitive training in executive functionsThe 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. - |
| active exercise only | Active comparator | Other: active exerciseThe 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. |
| Cognitive task trainig only | Active comparator | Other: cognitive task onlyThe 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- diagnosis migraine (diagnostic criteria of ICDH3-beta)
- Age over 18
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dual task protocol: active exercises with concomitant cognitive training in executive functionsThe 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. | Other | Dual task (active exercise and cognitive task) |
| active exercisePhysical activity and motor task only | Other | active exercise only |
| cognitive task onlycognitive exercise in executive functions | Other | Cognitive task trainig only |
Primary outcome
Values of Transcranial magnetic stimulation in migraine patients
Time frame: Before each treatment
Rest motor threshold in mV
Change from Baseline of the values of Transcranial magnetic stimulation in migraine patients at 3 months
Time frame: 3 months
Rest motor threshold in mV
Change from baseline of the value of Transcranial magnetic stimulation in migraine patients at 4 months
Time frame: 4 months
Rest motor threshold mV
6 secondary outcomes
Headache parameters and MIDAS
Time frame: Before each treatment
Headache parameters and MIDAS
Time frame: 3 months of each treatment
Headache parameters and MIDAS
Time frame: 4 months
Algometer Assessment
Time frame: Before each treatment
Algometer Assessment
Time frame: 3 months of each treatment
Algometer Assessment
Time frame: 4 months
Results and safety
The study was stopped early (reason given: Due to the unavailability of the subjects who gave the consent to participate to the study protocol). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dual task protocol: active exercises with concomitant cognitive training in executive functions, active exercise and cognitive task only in people with Migraine, run by University of Trieste at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Due to the unavailability of the subjects who gave the consent to participate to the study protocol). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Values of Transcranial magnetic stimulation in migraine patients (time frame: Before each treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2024.