Green Light and Transcranial Direct Current Stimulation in Migraine Patients

Riphah International University

Status: Enrolling

Conditions: Migraine

Treatments: Device: Sham transcranial direct current stimulation; Device: Green light; Device: Transcranial direct current stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06212869

REC01726 Amna Mehmood

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 3 patient groups

tDCS Group

Experimental group

Description:

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

Treatment:

Device: Transcranial direct current stimulation

Sham tDCS Group

Sham Comparator group

Description:

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

Treatment:

Device: Sham transcranial direct current stimulation

Green Light Group

Experimental group

Description:

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

Treatment:

Device: Green light