Green Light and Transcranial Direct Current Stimulation in Migraine Patients

NCT ID: NCT06212869

Last Updated: 2024-03-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-18
• Study Completion Date: 2024-10-31

Brief Summary

There is a lack of evidence on the clinical outcome of green light exposure, as it is the emerging, novel proposal of treatment. There are a lot of researches present with small sample size which should be done on large population. In last conducted studies, session numbers of the applied modality are less. There is no comparison of tDCS with green light for migraine. The literature suggested the neuromodulation influenced by these interventions that may result in reduction of migraine.

Detailed Description

Migraine treatments encompass both medicinal options, such as acute and preventive medications, as well as a variety of non-pharmacological therapies. The range of acute medications that are available can be categorized into four different treatment approaches for treating mild to moderate-severity attacks, which involve the use of acetaminophen and/or NSAIDs. For patients experiencing severe attacks or those who do not respond to the initial strategy, a triptan-based strategy is recommended. According to the American Academy of Neurology (AAN), there is strong supporting evidence for the effectiveness of several medications in preventing migraines, including metoprolol, timolol, propranolol, divalproex sodium, sodium valproate, and topiramate. There are some non-pharmacological approaches present like non-invasive and invasive neuromodulation. In non-invasive treatment, transcutaneous cranial nerve stimulation, vagus nerve stimulation, single-pulse transcranial magnetic stimulation (sTMS), transcranial direct current stimulation (tDCS), percutaneous mastoid stimulation and non-painful brachial electric stimulation are involved. In invasive neuromodulation, occipital nerve stimulation, sphenopalatine ganglion stimulation, and high cervical spine cord stimulation are involved.

Conditions

Migraine

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

tDCS Group

active tDCS with the prescribed medications for 20 minute. The intervention will conduct 3 consecutive days in a week.

Group Type: EXPERIMENTAL

Transcranial direct current stimulation

Intervention Type: DEVICE

tDCS group will give active tDCS with the prescribed medications for 20 minute. The intervention will conduct 3 consecutive days in a week.

Sham tDCS Group

sham tDCS with the prescribed medications for 20 minute. The intervention will conduct 3 consecutive days in a week.

Group Type: SHAM_COMPARATOR

Sham transcranial direct current stimulation

Intervention Type: DEVICE

Sham tDCS group will give sham tDCS with the prescribed medications for 20 minute. The intervention will conduct 3 consecutive days in a week.

Green Light Group

green light exposure with the prescribed medications for 1-2 hour. The intervention will conduct 5 days in a week.

Group Type: EXPERIMENTAL

Green light

Intervention Type: DEVICE

Green light group will give green light exposure with the prescribed medications for 1-2 hour. The intervention will conduct 5 days in a week.

Interventions

Transcranial direct current stimulation

tDCS group will give active tDCS with the prescribed medications for 20 minute. The intervention will conduct 3 consecutive days in a week.

Intervention Type: DEVICE

Sham transcranial direct current stimulation

Sham tDCS group will give sham tDCS with the prescribed medications for 20 minute. The intervention will conduct 3 consecutive days in a week.

Intervention Type: DEVICE

Green light

Green light group will give green light exposure with the prescribed medications for 1-2 hour. The intervention will conduct 5 days in a week.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Meet the diagnostic criteria established by the International Headache Society,
• patient must have had at least 5 headache attacks that lasted 4-72 hours (untreated or unsuccessfully treated)
• headache must have had at least 2 of the following characteristic; Unilateral location & Pulsating quality,
• An average headache pain intensity of migraine episodes of ≥5 at numeric pain scale (NPS) over the 10 weeks prior to enrolling in the study.

Exclusion Criteria

• Mental illness,
• Photophobic individual,
• Presence of shunt and/or implant at the cranial region,
• Brain tumors,
• Wound at skull

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mirza Obaid Baig, MSPT

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Pakistan Railway General Hospital

Rawalpindi, Punjab Province, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

Amna Mehmood, DPT

Role: CONTACT

amnamahmood883@gmail.com

00923364217152

Mirza Obaid Baig, MSPT

Role: CONTACT

obaid.baig@riphah.edu.pk

00923332238706

Facility Contacts

Amna Mehmood, DPT

Role: primary

amnamahmood883@gmail.com

00923364217152

Mirza Obaid Baig, MSPT

Role: backup

obaid.baig@riphah.edu.pk

0092 333 2238706

References

Ferrari MD, Goadsby PJ, Burstein R, Kurth T, Ayata C, Charles A, Ashina M, van den Maagdenberg AMJM, Dodick DW. Migraine. Nat Rev Dis Primers. 2022 Jan 13;8(1):2. doi: 10.1038/s41572-021-00328-4.

Reference Type: BACKGROUND

PMID: 35027572 (View on PubMed)

Andreou AP, Edvinsson L. Mechanisms of migraine as a chronic evolutive condition. J Headache Pain. 2019 Dec 23;20(1):117. doi: 10.1186/s10194-019-1066-0.

Reference Type: BACKGROUND

PMID: 31870279 (View on PubMed)

Martin LF, Patwardhan AM, Jain SV, Salloum MM, Freeman J, Khanna R, Gannala P, Goel V, Jones-MacFarland FN, Killgore WD, Porreca F, Ibrahim MM. Evaluation of green light exposure on headache frequency and quality of life in migraine patients: A preliminary one-way cross-over clinical trial. Cephalalgia. 2021 Feb;41(2):135-147. doi: 10.1177/0333102420956711. Epub 2020 Sep 9.

Reference Type: BACKGROUND

PMID: 32903062 (View on PubMed)

Puledda F, Silva EM, Suwanlaong K, Goadsby PJ. Migraine: from pathophysiology to treatment. J Neurol. 2023 Jul;270(7):3654-3666. doi: 10.1007/s00415-023-11706-1. Epub 2023 Apr 8.

Reference Type: BACKGROUND

PMID: 37029836 (View on PubMed)

Hussain G, Rasul A, Anwar H, Sohail MU, Kamran SKS, Baig SM, et al. Epidemiological data of neurological disorders in Pakistan and neighboring countries: a review. Pakistan Journal of Neurological Sciences (PJNS). 2017;12(4):52-70.

Reference Type: BACKGROUND

Other Identifiers

REC01726 Amna Mehmood

Identifier Type: -

Identifier Source: org_study_id