Repetitive Transcranial Magnetic Stimulation in Treatment and Prophylaxis of Chronic Migraine in Patients With no Prophylactic Treatment for the Last 3 Months

NCT ID: NCT06461767

Last Updated: 2024-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2025-01-01

Brief Summary

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Compared with the patients with episodic migraine those with chronic migraine have worst quality of life and more severe headache related disability we investigate Repetitive transcranial magnetic stimulation in treatment and prophylaxis of chronic migraine

Detailed Description

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Conditions

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Chronic Migraine

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

the patient will divide into 4 groups first group will receive stimulation over the left motor cortex second group will receive stimulation over left dorsolateral prefrontal cortex third group will receive stimulation over both left motor cortex and left dorsolateral prefrontal cortex fourth group will receive sham stimulation
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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group (1) will rTMS over left motor cortex

Repetitive transcranial magnetic stimulation parameters:

stimulation site: left motor cortex intensity: 70% of resting motor threshold frequency: 15 Hz number of pulses: 30 number of trains: 40

Group Type ACTIVE_COMPARATOR

transcranial magnetic stimulation device

Intervention Type DEVICE

Repetitive transcranial magnetic stimulation parameters:

stimulation site: left dorsolateral prefrontal cortex and left motor cortex intensity: 70% of resting motor threshold frequency: 15 Hz number of pulses: 30

group (2) will receive rTMS over left dorsolateral prefrontal cortex

Repetitive transcranial magnetic stimulation parameters:

stimulation site: left dorsolateral prefrontal cortex intensity: 70% of resting motor threshold frequency: 15 Hz number of pulses: 30 number of trains: 40

Group Type ACTIVE_COMPARATOR

transcranial magnetic stimulation device

Intervention Type DEVICE

Repetitive transcranial magnetic stimulation parameters:

stimulation site: left dorsolateral prefrontal cortex and left motor cortex intensity: 70% of resting motor threshold frequency: 15 Hz number of pulses: 30

group (3) will receive rTMS over left dorsolateral prefrontal cortex and left motor cortex

Repetitive transcranial magnetic stimulation parameters:

stimulation site: left dorsolateral prefrontal cortex and left motor cortex intensity: 70% of resting motor threshold frequency: 15 Hz number of pulses: 30 number of trains: 40

Group Type ACTIVE_COMPARATOR

transcranial magnetic stimulation device

Intervention Type DEVICE

Repetitive transcranial magnetic stimulation parameters:

stimulation site: left dorsolateral prefrontal cortex and left motor cortex intensity: 70% of resting motor threshold frequency: 15 Hz number of pulses: 30

group (4) will receive sham stimulation

Repetitive transcranial magnetic stimulation parameters:

stimulation site: the coil will be perpendicular over vertex of skull intensity: 70% of resting motor threshold frequency: 15 Hz number of pulses: 30 number of trains: 40

Group Type SHAM_COMPARATOR

transcranial magnetic stimulation device

Intervention Type DEVICE

Repetitive transcranial magnetic stimulation parameters:

stimulation site: left dorsolateral prefrontal cortex and left motor cortex intensity: 70% of resting motor threshold frequency: 15 Hz number of pulses: 30

Interventions

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transcranial magnetic stimulation device

Repetitive transcranial magnetic stimulation parameters:

stimulation site: left dorsolateral prefrontal cortex and left motor cortex intensity: 70% of resting motor threshold frequency: 15 Hz number of pulses: 30

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* A study sample of patients with chronic migraine according to international classification of headache disorders-3 (ICHD-3).
* Patients are regular on follow up visits.

Exclusion Criteria

* Patients with depression by Hamiliton scale of depression by using its Arabic version Translated by Dr Lotfy Fateem
* patients on prophylactic medications for chronic migraine.
* pregnancy.
* cochlear implants, cardiac pacemaker, and metal body implanted in head-and-neck region.
* Patients refused to give informed consent.
* History of seizures.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Tarik Mohamed Abdelnaeem

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tarek Mohamed

Role: PRINCIPAL_INVESTIGATOR

Sohag faculty of medicine

Locations

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Sohag faculty of medicine

Sohag, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Tarek Mohamed

Role: CONTACT

01025545002

Facility Contacts

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Tarek Mohamed

Role: primary

01025545002

Other Identifiers

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Soh-Med-24-05-06MS

Identifier Type: -

Identifier Source: org_study_id

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