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

NCT06461767 | Recruiting

• 1 other identifier: Soh-Med-24-05-06MS
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Migraine

Outcome Measures

Primary Outcomes (1)

• improvement of headache severity and number of attacks of headache before and after intervention by visual analogue scale and headache impact test

  improvement of headache severity and number of attacks of headache before and after intervention by visual analogue scale and headache impact test

  one month after treatment

Study Arms (4)

group (1) will rTMS over left motor cortex

ACTIVE COMPARATOR

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

Device: transcranial magnetic stimulation device

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

ACTIVE COMPARATOR

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

Device: transcranial magnetic stimulation device

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

ACTIVE COMPARATOR

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

Device: transcranial magnetic stimulation device

group (4) will receive sham stimulation

SHAM COMPARATOR

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

Device: transcranial magnetic stimulation device

Interventions

transcranial magnetic stimulation device 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 (1) will rTMS over left motor cortex; group (2) will receive rTMS over left dorsolateral prefrontal cortex; group (3) will receive rTMS over left dorsolateral prefrontal cortex and left motor cortex; group (4) will receive sham stimulation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag faculty of medicine

Sohag, 02, Egypt

RECRUITING

Study Officials

• Tarek Mohamed

  Sohag faculty of medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tarek Mohamed

CONTACT

01025545002; tarikmohamed@med.sohag.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: 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

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: June 17, 2024
• Study Start: January 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: June 18, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

EG (1)