Combined Effects of Green Light and Transcranial Direct Current Stimulation in Migraine Patients.
NCT ID: NCT06943625
Last Updated: 2026-01-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
40 participants
INTERVENTIONAL
2025-04-24
2026-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Repetitive Transcranial Magnetic Stimulation in Treatment and Prophylaxis of Chronic Migraine in Patients With no Prophylactic Treatment for the Last 3 Months
NCT06461767
Evaluation of the Prophylactic Efficacy of tDCS in Chronic Migraine
NCT02120326
Vagal Nerve Stimulation and Pain Frequency, Intensity in Chronic Migraine
NCT06191016
Cranial Electrotherapy Stimulation in the Treatment of Migraine Headaches
NCT01265797
TCDS for the Treatment of Chronic Migraine
NCT07214454
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group 1
tDCS will applied to the participants of this group along with medication advised
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
medicine
Advised medicine by the medical doctors will be utilized by the participants of the study
Group 2
Green light exposure will be provided to the participants of this group along with the medications advised.
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.
medicine
Advised medicine by the medical doctors will be utilized by the participants of the study
Group 3
tDCS and green light will be provided to the participants of this group along with the medications advised
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
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.
medicine
Advised medicine by the medical doctors will be utilized by the participants of the study
Group 4
Only advised medication will be utilized by the participants in this group
medicine
Advised medicine by the medical doctors will be utilized by the participants of the study
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
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.
medicine
Advised medicine by the medical doctors will be utilized by the participants of the study
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Photophobic individual
* Presence of shunt and/or implant at the cranial region
* Brain tumors
* Wound at skull
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Riphah International University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Mirza Obaid Baig, MSPT
Role: PRINCIPAL_INVESTIGATOR
Riphah International University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Pakistan Railway Hospital
Rawalpindi, Punjab Province, Pakistan
Pakistan Railway Hospital
Rawalpindi, Punjab Province, Pakistan
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Moisset X, Pereira B, Ciampi de Andrade D, Fontaine D, Lanteri-Minet M, Mawet J. Neuromodulation techniques for acute and preventive migraine treatment: a systematic review and meta-analysis of randomized controlled trials. J Headache Pain. 2020 Dec 10;21(1):142. doi: 10.1186/s10194-020-01204-4.
Stovner LJ, Hagen K, Linde M, Steiner TJ. The global prevalence of headache: an update, with analysis of the influences of methodological factors on prevalence estimates. J Headache Pain. 2022 Apr 12;23(1):34. doi: 10.1186/s10194-022-01402-2.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
REC02167 Sufia Umar
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.