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Device

tDCS for Cervicogenic Headache

N/A

Recruiting

Led By Chantel T Debert, MD MSc FRCPC CSCN

Research Sponsored by University of Calgary

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up to be assessed throughout the 6 weeks of treatment and at the 6 and 12 week follow up

Awards & highlights

Study Summary

This trial looks into the safety and feasibility of using transcranial direct current stimulation (tDCS) and physiotherapy to help up to 150,000 Canadians affected by chronic cervicogenic headaches.

Who is the study for?

This trial is for individuals with cervicogenic headaches lasting over 12 weeks, with pain scores of at least 4/10 and neck disability scores of at least 28/50. It's not suitable for those with other primary or mixed headaches, nerve root pain, inflammatory conditions, recent surgery within a year, neurological issues, psychiatric conditions, contraindications to tDCS like metal implants in the head or body issues.Check my eligibility

What is being tested?

The study tests the safety and effectiveness of Transcranial Direct Current Stimulation (tDCS) combined with physiotherapy compared to sham stimulation plus physiotherapy in treating chronic cervicogenic headaches. Participants will be randomly assigned to either real tDCS treatment or a placebo-like sham intervention.See study design

What are the potential side effects?

Potential side effects from tDCS may include mild tingling on the scalp, itching under the electrode area during stimulation, fatigue after treatment sessions, headache following stimulation or skin redness where electrodes are placed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ to be assessed throughout the 6 weeks of treatment and at the 6 and 12 week follow up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~to be assessed throughout the 6 weeks of treatment and at the 6 and 12 week follow up

This trial's timeline: 3 weeks for screening, Varies for treatment, and to be assessed throughout the 6 weeks of treatment and at the 6 and 12 week follow up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Feasibility of tDCS through change in participant rate, change in pain intensity, frequency, and duration, and change in medication usage

Safety of tDCS through change in adverse effect rates from before treatment to after.

Secondary outcome measures

Cervical Extensor Endurance Test (CEET)

Cervical Cap

Craniocervical Flexion Test (CCFT)

+12 more

Other outcome measures

Exercise diary

Headache

Side effects data

From 2021 Phase 2 & 3 trial • 160 Patients • NCT02483468

Car accident

skin irritation

100%

80%

60%

40%

20%

Study treatment Arm

tDCS (Active)

tDCS (Sham)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active tDCS with physiotherapyExperimental Treatment1 Intervention

Patients will engage in a six-week treatment protocol with 3 sessions per week (18 treatments). This was chosen to minimize discomfort and ensure the number of sessions is consistent with previous migraine literature. The primary motor cortex (M1) will be the treatment target to reduce pain sensitivity and improve motor learning. M1 will be found through measurements of the head: the point halfway between the nasion and inion and halfway between the left and right tragus will be found, we will then move down 20% of the inter-tragi distance and place the anode there. The cathode will then be placed over the super orbital region. Each electrode will be held in place with a strap and will make as much contact with the skin as possible. tDCS will be delivered via two 35cm2 surface sponge electrodes at an intensity of 2mA in the active group.

Group II: Sham tDCS with physiotherapyPlacebo Group1 Intervention

In the sham condition, the number of sessions, placement of electrodes, and types of electrodes used will be the same, however, only a 30 second ramp up period will be administered to emulate active tDCS therapy. Patients will be able to hear the sounds of the device and will feel slight tingling for the first 30 seconds but will receive no active stimulation. Previous sham studies have demonstrated efficacy of the blinding method.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Transcranial Direct Current Stimulation

2014

Completed Phase 3

~1100

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of CalgaryLead Sponsor

792 Previous Clinical Trials

869,122 Total Patients Enrolled

Alberta Health servicesOTHER

158 Previous Clinical Trials

649,634 Total Patients Enrolled

Chantel T Debert, MD MSc FRCPC CSCNPrincipal InvestigatorUniversity of Calgary

1 Previous Clinical Trials

91 Total Patients Enrolled

Media Library

Sham Transcranial Direct Current Stimulation (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05582616 — N/A

Cervicogenic Headache Research Study Groups: Active tDCS with physiotherapy, Sham tDCS with physiotherapy

Cervicogenic Headache Clinical Trial 2023: Sham Transcranial Direct Current Stimulation Highlights & Side Effects. Trial Name: NCT05582616 — N/A

Sham Transcranial Direct Current Stimulation (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05582616 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open enrollment opportunities for this research study?

"As per clinicaltrials.gov, this medical trial is enrolling participants at the moment and was initially posted on November 3rd 2022 with its most recent modification occurring on November 30th of the same year."

Answered by AI

Is this trial open to those aged 55 or greater?

"This trial is open to applicants between 18 and 65 years old. In contrast, there are 19 other clinical trials for patients under the age of majority, as well as 91 studies that target elderly individuals over the age of 65."

Answered by AI

Who meets the criteria to participate in this medical experiment?

"This clinical trial is seeking 40 individuals aged 18-65 who have been diagnosed with cervicogenic headaches in accordance to the International Headache Society Guidelines. These participants must also report an average pain score of 4/10 or greater, and Neck Disability scores 28/50 or higher. Additionally, it should be demonstrated that their migraine developed in temporal relation to a cervical disorder (or lesion), improved in parallel with improvement of said condition, was exacerbated by limited neck mobility, and subsided after diagnostic blockade of a relevant structure or nerve supply."

Answered by AI

How many individuals have registered for this research project?

"Affirmative. According to the information hosted on clinicaltrials.gov, this health study is actively recruiting patients as of November 30th 2022. It initially posted on November 3rd and requires 40 participants for its single site-location."

Answered by AI

In what ways is this research endeavor anticipated to yield positive results?

"The primary purpose of this 6-week trial is to assess the safety of tdcs by measuring adverse effect rates. Secondary outcomes include Dynamometry Neck Strength Assessment (DNSA), Headache Impact Test-6 (HIT-6) and European Quality of Life 5 Dimension (EQ-5D). DNSA measures neck muscle strength, HIT-6 evaluates headache intensity on a scale from 36 to 78 with higher scores indicating more severe symptoms, while EQ–5D tracks quality of life between 0 and 25 where higher numbers connote poorer wellbeing."

Answered by AI

Recent research and studies

Journal of General Internal MedicineJournal

The PHQ-9

Kroenke, Kurt, Robert L. Spitzer, and Janet B. W. Williams. 2001. “The PHQ-9”. Journal of General Internal Medicine. Springer Science and Business Media LLC. doi:10.1046/j.1525-1497.2001.016009606.x.

Physiotherapy CanadaJournal

Evaluating the Reliability of a Novel Neck-strength Assessment Protocol for Healthy Adults Using Self-generated Resistance with a Hand-held Dynamometer

Versteegh, Theo, Danielle Beaudet, Marla Greenbaum, Leah Hellyer, Amanda Tritton, and Dave Walton. 2015. “Evaluating the Reliability of a Novel Neck-strength Assessment Protocol for Healthy Adults Using Self-generated Resistance with a Hand-held Dynamometer”. Physiotherapy Canada. University of Toronto Press Inc. (UTPress). doi:10.3138/ptc.2013-66.

Clinical NeurophysiologyJournal

Low Intensity Transcranial Electric Stimulation: Safety, Ethical, Legal Regulatory and Application Guidelines

Antal, A., I. Alekseichuk, M. Bikson, J. Brockmöller, A.R. Brunoni, R. Chen, L.G. Cohen, et al.. 2017. “Low Intensity Transcranial Electric Stimulation: Safety, Ethical, Legal Regulatory and Application Guidelines”. Clinical Neurophysiology. Elsevier BV. doi:10.1016/j.clinph.2017.06.001.

Medical CareJournal