Clinical trial NCT06212869: Green Light and Transcranial Direct Current Stimulation in Migraine Patients
Official title: Green Light and Transcranial Direct Current Stimulation in Migraine Patients; a Randomized Control Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Migraine
Keywords: migraine
green light
transcranial direct current stimulation
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-01-19
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Structured Headache Diary Data for frequency of migraine
timeFrame: Week 4
measure: Numeric Pain Scale (NPS) for intensity of migraine
timeFrame: Week 4
measure: Multidimensional pain inventory (MPI) for migraine impact
timeFrame: Week 4
Secondary outcomes:
measure: Migraine-specific Quality of Life Survey (MSQ 2.1) for quality of life
timeFrame: Week 4
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Pakistan Railway General Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Mirza Obaid Baig, MSPT
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.