Green Light and Transcranial Direct Current Stimulation in Migraine Patients

NCT06212869 | Recruiting

• 1 other identifier: REC01726 Amna Mehmood
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine

Keywords

migraine; green light; transcranial direct current stimulation

Outcome Measures

Primary Outcomes (3)

• Structured Headache Diary Data for frequency of migraine

  diaries make it possible to record prospectively the characteristics of every attack and the use of headache calendars is indicated for evaluating the time pattern of headache, identifying aggravating factors and evaluating the efficacy of preventive treatment. This may reduce the recall bias and increase accuracy in the description.

  Week 4

• Numeric Pain Scale (NPS) for intensity of migraine

  NPS was implemented in clinical practice due to its rapidity both verbally and in writing. Due to its convenience, it is common for hospitals to measure pain using the 0 to 10 NPS scale.

  Week 4

• Multidimensional pain inventory (MPI) for migraine impact

  Multidimensional Pain Inventory (MPI) is one of the most widely used multidimensional instruments to measure adaptation to pain. It is a self-administered questionnaire comprising 12 empirically derived scales that measure dimensions of pain perception, life interference due to pain, perception of life control, affective distress, and social support. The instrument uses a clustering approach to derive three distinct subgroups: Dysfunctional (Dys), interpersonally distressed (ID), and adaptive copers (AC).

  Week 4

Secondary Outcomes (1)

• Migraine-specific Quality of Life Survey (MSQ 2.1) for quality of life

  Week 4

Study Arms (3)

tDCS Group

EXPERIMENTAL

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

Device: Transcranial direct current stimulation

Sham tDCS Group

SHAM COMPARATOR

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

Device: Sham transcranial direct current stimulation

Green Light Group

EXPERIMENTAL

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

Device: Green light

Interventions

Transcranial direct current stimulation DEVICE

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

tDCS Group

Sham transcranial direct current stimulation DEVICE

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

Sham tDCS Group

Green light DEVICE

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

Green Light Group

Eligibility Criteria

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

You may qualify if:

• 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.

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 (1)

Pakistan Railway General Hospital

Rawalpindi, Punjab Province, Pakistan

RECRUITING

Related Publications (5)

• 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.

  PMID: 35027572 BACKGROUND

• 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.

  PMID: 31870279 BACKGROUND

• 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.

  PMID: 32903062 BACKGROUND

• 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.

  PMID: 37029836 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Migraine Disorders

Interventions

Transcranial Direct Current Stimulation

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

Study Officials

• Mirza Obaid Baig, MSPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amna Mehmood, DPT

CONTACT

00923364217152; amnamahmood883@gmail.com

Mirza Obaid Baig, MSPT

CONTACT

00923332238706; obaid.baig@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: January 19, 2024
• Study Start: January 18, 2024
• Primary Completion: September 30, 2024
• Study Completion: October 31, 2024
• Last Updated: March 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)