Non-pharmacological Treatments in Migraine.

NCT05596058 | Terminated DMC

• 1 other identifier: 080_2020
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Migraine

Keywords

Migraine; Habituation; Sensitization; transcranial Magnetic stimulation

Outcome Measures

Primary Outcomes (3)

• Values of Transcranial magnetic stimulation in migraine patients

  Rest motor threshold in mV

  Before each treatment

• Change from Baseline of the values of Transcranial magnetic stimulation in migraine patients at 3 months

  Rest motor threshold in mV

  3 months

• Change from baseline of the value of Transcranial magnetic stimulation in migraine patients at 4 months

  Rest motor threshold mV

  4 months

Secondary Outcomes (6)

• Headache parameters and MIDAS

  Before each treatment

• Headache parameters and MIDAS

  3 months of each treatment

• Headache parameters and MIDAS

  4 months

• Algometer Assessment

  Before each treatment

• Algometer Assessment

  3 months of each treatment

Other Outcomes (4)

• Neuropsychological tests

  Before each treatment

• Neuropsychological tests

  3 months of each treatment

• Neuropsychological tests

  4 months

Study Arms (3)

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. \-

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.

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).

Other: cognitive task only

Interventions

dual task protocol: active exercises with concomitant cognitive training in executive functions OTHER

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.

Dual task (active exercise and cognitive task)

active exercise OTHER

Physical activity and motor task only

active exercise only

cognitive task only OTHER

cognitive exercise in executive functions

Cognitive task trainig only

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Trieste: lead

Study Sites (1)

Manuela Deodato

Trieste, TS, 34148, Italy

Location

MeSH Terms

Conditions

Migraine Disorders; Substance-Related Disorders

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients do not know other type of intervention; who have to do the assessment do not know the type of interventions
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: May 23, 2022
• First Posted: October 27, 2022
• Study Start: June 1, 2022
• Primary Completion: October 1, 2022
• Study Completion: November 1, 2023
• Last Updated: February 1, 2024

Record last verified: 2024-01

Locations

IT (1)