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

NCT06943625 | Recruiting

• 1 other identifier: REC02167 Sufia Umar
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Migraine

Keywords

migraine; neuromodulation; brain stimulation

Outcome Measures

Primary Outcomes (2)

• Structured Headache Diary Data

  Structured Headache Diary Data for frequency of migraine

  4 week

• Numeric Pain Scale

  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 Outcomes (2)

• Multidimensional Pain Inventory

  4 week

• Migraine-Specific Quality of Life Survey

  4 week

Study Arms (4)

Group 1

ACTIVE COMPARATOR

tDCS will applied to the participants of this group along with medication advised

Other: tDCS; Other: medicine

Group 2

ACTIVE COMPARATOR

Green light exposure will be provided to the participants of this group along with the medications advised.

Other: Green light; Other: medicine

Group 3

EXPERIMENTAL

tDCS and green light will be provided to the participants of this group along with the medications advised

Other: tDCS; Other: Green light; Other: medicine

Group 4

ACTIVE COMPARATOR

Only advised medication will be utilized by the participants in this group

Other: medicine

Interventions

tDCS OTHER

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

Group 1; Group 3

Green light OTHER

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.

Group 2; Group 3

medicine OTHER

Advised medicine by the medical doctors will be utilized by the participants of the study

Group 1; Group 2; Group 3; Group 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (2)

Pakistan Railway Hospital

Rawalpindi, Punjab Province, 466000, Pakistan

RECRUITING

Pakistan Railway Hospital

Rawalpindi, Punjab Province, Pakistan

NOT YET RECRUITING

Related Publications (2)

• 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.

  PMID: 33302882 BACKGROUND

• 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.

  PMID: 35410119 BACKGROUND

MeSH Terms

Conditions

Migraine Disorders

Interventions

Transcranial Direct Current Stimulation; Green Light; Dosage Forms

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Sunlight; Light; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Optical Phenomena; Radiation; Radiation, Nonionizing; Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Study Officials

• Mirza Obaid Baig, MSPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sufia Omar, DPT

CONTACT

00923341827272; sofo.umar97@gmail.com

Mirza Obaid Baig, MSPT

CONTACT

00923332238706; obaid.baig@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2025
• First Posted: April 24, 2025
• Study Start: April 24, 2025
• Primary Completion: March 31, 2026
• Study Completion: April 30, 2026
• Last Updated: January 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (2)