Combined Effects of Green Light and Transcranial Direct Current Stimulation in Migraine Patients.

December 29, 2025 updated by: Riphah International University

Combined Effects of Green Light and Transcranial Direct Current Stimulation on Migraine Intensity and Frequency in Migraine Patients.

According to the Global Burden of Disease (GBD) study, headache disorders are among the most prevalent and disabling conditions worldwide, with estimated 1-year prevalence of migraine (22.5%) in Pakistan, considerably higher than the global 1-year prevalence of 15%.

The treatment options comprise such as lifestyle modifications, behavioral therapy, medication such as nonsteroidal anti-inflammatory drugs (NSAIDs), beta blockers, calcium channel blockers, antiepileptic drugs or antibodies against calcitonin gene-related peptide (CGRP) or its receptor, and neuromodulation.

One of the non-invasive neuromodulation technique is used in migraine patients .i.e., transcranial direct current stimulation (tDCS), tDCS is a promising method for migraine treatment delivering a low-intensity current through the scalp by means of electrodes to modulate the state of polarization of the cerebral cortex; depending on the polarity of the electrical stimulation, tDCS can be either anodal(excitatory) or cathodal(inhibitory). Neuromodulation by tDCS is thought to follow Hebbian Theory ("neurons that fire together, wire together"). If presynaptic and postsynaptic neurons are both active, the result is synaptic strengthening; if one or both are inactive, no change occurs. The literature reported significant reduction in migraine days when applying tDCS to the occipital cortex, primary motor cortex, or the dorsolateral prefrontal cortex. The advantages of tDCS treatment are its relatively low cost compared to other neurostimulator methods, safety and generally mild side effects.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Migraine is a common and debilitating neurological disorder, defined as "an episodic headache associated with certain features, such as sensitivity to light, sound, or movement", classified by headache frequency, with chronic migraine (CM), defined as 15 or more headache days a month for three or more months while episodic migraine (EM), is defined as occurring on fewer than 15 headache days per month.

It is also known as a common relapsing headache disease with a huge socioeconomic burden, characterized by a headache lasting 4 - 72 hours when untreated, which tends to be unilateral, pulsating, and of moderate to severe pain intensity.

According to the Global Burden of Disease (GBD) study, headache disorders are among the most prevalent and disabling conditions worldwide, with estimated 1-year prevalence of migraine (22.5%) in Pakistan, considerably higher than the global 1-year prevalence of 15%.

In the international classification of headache disorders 3rd Edition (ICHD-3), migraines may be diagnosed with aura or without aura. Migraine with aura is a complex neurological manifesting clinically as visual, somatosensory, speech or motor symptoms that precedes the headache phase. Migraine without aura is a recurrent headache disorder with specific features like unilateral, pulsating pain, nausea, and light/sound sensitivity, lasting between 4 and 72 hours.

The Graham and Wolff proposed the vascular theory for migraines, which stated that the serotonin released from the platelets in blood vessels to be the causal molecule. Because serotonin has constrictive effects on blood vessels, local cerebral blood flow is decreased, and this was thought to cause the auras that occur in migraines. After the reuptake or metabolism of this serotonin, the constricted blood vessels dilate, inducing the pain of the migraine headache.

The primary cause of migraines is the activation of the cervical complex of the trigeminal nucleus and trigeminal nerve. This activation of the trigeminal nerve results in neurogenic inflammation, including CGRP release from the C-fibers of the trigeminal ganglion and peripheral trigeminal nerve terminal. CGRP receptors are located in larger neurons and thicker fibers, which correspond to the Aδ-fibers of the trigeminal nerve. A δ-fibers are myelinated nociceptive nerves; thus, stimulation of Aδ-fiber CGRP receptors causes sharp severe headaches. The activation of the trigeminovascular system, mostly pertaining to the peripheral nervous system, is the key event of migraine pain generation.

The treatment options comprise such as lifestyle modifications, behavioral therapy, medication such as nonsteroidal anti-inflammatory drugs (NSAIDs), beta blockers, calcium channel blockers, antiepileptic drugs or antibodies against calcitonin gene-related peptide (CGRP) or its receptor, and neuromodulation. Neuromodulation can be defined as an intervention that potentiates or inhibits the transmission of a nerve impulse but is not the actual means of transmission itself.

One of the non-invasive neuromodulation technique is used in migraine patients .i.e., transcranial direct current stimulation (tDCS), tDCS is a promising method for migraine treatment delivering a low-intensity current through the scalp by means of electrodes to modulate the state of polarization of the cerebral cortex; depending on the polarity of the electrical stimulation, tDCS can be either anodal(excitatory) or cathodal(inhibitory). Neuromodulation by tDCS is thought to follow Hebbian Theory ("neurons that fire together, wire together"). If presynaptic and postsynaptic neurons are both active, the result is synaptic strengthening; if one or both are inactive, no change occurs. The literature reported significant reduction in migraine days when applying tDCS to the occipital cortex, primary motor cortex, or the dorsolateral prefrontal cortex. The advantages of tDCS treatment are its relatively low cost compared to other neuro-stimulation methods, safety and generally mild side effects.

Reports suggested that exposure to lights of different wavelengths can affect nociception in rodents. For example, exposure to a green light emitting diode (GLED) resulted in anti-nociception in naïve rats and anti-hyperalgesia in rats with neuropathic pain that was dependent on engagement of the visual system. Also exploratory studies demonstrated that isolated exposure to green light may reduce the intensity and duration of migraine attacks.

The rationale for this study is to evaluate whether combining tDCS with green light exposure provides synergistic benefits in reducing migraine frequency, intensity, and improving the overall quality of life for patients suffering from migraine. This dual approach may enhance therapeutic outcomes by targeting both the neural mechanisms underlying migraine attacks through neuromodulation (tDCS) and alleviating visual discomfort via green light.

The proposed study seeks to address a gap in current migraine treatment by exploring the potential of a non-pharmacological, combinatory intervention that could offer a more effective, lasting solution for migraine management. Given the growing interest in non-pharmacological treatments for migraine and the promise of both tDCS and green light exposure, this research will hold significant potential for advancing migraine care and providing new treatment options for patients who prefer or require alternatives to conventional medications.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Pakistan
    • Punjab Province
      • Rawalpindi, Punjab Province, Pakistan, 466000
        • Recruiting
        • Pakistan Railway Hospital
        • Contact:
        • Principal Investigator:
          • Mirza Obaid Baig, MSPT
      • Rawalpindi, Punjab Province, Pakistan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Episodic migraine or chronic migraine according to the International Headache Society
  • An average headache pain intensity of migraine episodes of ≥5 at numeric pain scale (NPS) over the 4 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1
tDCS will applied to the participants of this group along with medication advised
Other: tDCS

Transcranial direct current stimulation protocol involves 20 minutes of anodal stimulation, with the anodal electrode placed over the motor cortex (primary motor area), and cathodal stimulation applied to the contralateral supraorbital area.

The intensity of the current will be set to 1.5 mA, with the current density ranging from approximately 0.03 to 0.06 mA, with the electrode measuring of 5x7cm. To ensure a gradual and comfortable experience for participants, the current will ramp up and down over 30 seconds at the beginning and end of each session. Each stimulation session will last for 20 minutes, with participants undergoing five sessions per week. The entire intervention protocol will be carried out over a period of four weeks

Other: medicine
Advised medicine by the medical doctors will be utilized by the participants of the study
Active Comparator: Group 2
Green light exposure will be provided to the participants of this group along with the medications advised.
Other: medicine
Advised medicine by the medical doctors will be utilized by the participants of the study
Other: Green light
Green light exposure will be administered using light with a wavelength of about 520 nm. The sessions will take place in a dimly lit room to minimize external light interference and enhance the therapeutic effect of the green light. Each exposure session will last for 2 hours, with participants receiving 3 to 5 sessions per week. The light intensity will be set to 100 lux, a level that is both safe and effective for migraine treatment. The entire intervention protocol will span over four weeks to allow for sufficient evaluation of the effects. During each session, participants will be seated comfortably in a chair to ensure they are relaxed and able to tolerate light exposure without discomfort.
Experimental: Group 3
tDCS and green light will be provided to the participants of this group along with the medications advised
Other: tDCS

Transcranial direct current stimulation protocol involves 20 minutes of anodal stimulation, with the anodal electrode placed over the motor cortex (primary motor area), and cathodal stimulation applied to the contralateral supraorbital area.

The intensity of the current will be set to 1.5 mA, with the current density ranging from approximately 0.03 to 0.06 mA, with the electrode measuring of 5x7cm. To ensure a gradual and comfortable experience for participants, the current will ramp up and down over 30 seconds at the beginning and end of each session. Each stimulation session will last for 20 minutes, with participants undergoing five sessions per week. The entire intervention protocol will be carried out over a period of four weeks

Other: medicine
Advised medicine by the medical doctors will be utilized by the participants of the study
Other: Green light
Green light exposure will be administered using light with a wavelength of about 520 nm. The sessions will take place in a dimly lit room to minimize external light interference and enhance the therapeutic effect of the green light. Each exposure session will last for 2 hours, with participants receiving 3 to 5 sessions per week. The light intensity will be set to 100 lux, a level that is both safe and effective for migraine treatment. The entire intervention protocol will span over four weeks to allow for sufficient evaluation of the effects. During each session, participants will be seated comfortably in a chair to ensure they are relaxed and able to tolerate light exposure without discomfort.
Active Comparator: Group 4
Only advised medication will be utilized by the participants in this group
Other: medicine
Advised medicine by the medical doctors will be utilized by the participants of the study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Structured Headache Diary Data
Time Frame: 4 week
Structured Headache Diary Data for frequency of migraine
4 week
Numeric Pain Scale
Time Frame: 4 week
Numeric Pain Scale (NPS) for intensity of migraine, is a simple 0-10 tool for measuring pain intensity, where 0 is "no pain" and 10 is "worst pain
4 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Multidimensional Pain Inventory
Time Frame: 4 week
Multidimensional Pain Inventory (MPI) for migraine impact, is scored by summing responses to specific items (rated 0-6) for various subscales, then calculating a mean score (e.g., (Q1+Q7+Q12)/3 for Pain Severity), providing 12 distinct scores across Pain Impact, Significant Other Responses, and Activity levels, helping clinicians understand pain's breadth, not just severity, with higher scores generally indicating greater impact or distress, though some scales (like Activity) use higher scores for more function.
4 week
Migraine-Specific Quality of Life Survey
Time Frame: 4 week
Migraine-Specific Quality of Life Survey (MSQ 2.1) for quality of life, involves rating 14 items on a 6-point scale (1=All the time, 6=None of the time) across three domains (Role-Restrictive, Role-Preventive, Emotional Function), summing item scores, and then rescaling them to a 0-100 scale where higher scores mean better quality of life, reflecting how migraines impact daily activities, work, and feelings over the past four weeks.
4 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Mirza Obaid Baig, MSPT, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 24, 2025

Primary Completion (Estimated)

March 31, 2026

Study Completion (Estimated)

April 30, 2026

Study Registration Dates

First Submitted

April 17, 2025

First Submitted That Met QC Criteria

April 17, 2025

First Posted (Actual)

April 24, 2025

Study Record Updates

Last Update Posted (Actual)

January 5, 2026

Last Update Submitted That Met QC Criteria

December 29, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC02167 Sufia Umar

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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