What side effects are associated with this type of intervention?

Transcranial direct current stimulation (tDCS) is generally well-tolerated, with mild side effects such as a warm sensation, itching, tingling, and redness at the site of stimulation. Rarely, it may cause headaches or dizziness. Physiotherapy, which includes physical rehabilitation techniques, is also considered safe but can sometimes lead to temporary muscle soreness, fatigue, or discomfort during or after sessions. Both treatments have a high degree of safety and are commonly used for managing chronic pain conditions.

What prior FDA approvals exist?

There is no specific mention of FDA approvals for the treatment of cervicogenic headache using transcranial direct current stimulation (tDCS) or physiotherapy in the provided context. However, both tDCS and physiotherapy are recognized as safe interventions for various chronic pain conditions and headache disorders. tDCS modulates neuronal activity, while physiotherapy focuses on physical rehabilitation. These treatments are being studied for their feasibility and safety in managing cervicogenic headaches.

What other types of research exist?

Promising novel alternatives to tDCS and physiotherapy for cervicogenic headache patients include Transcranial Magnetic Stimulation (TMS), which has shown efficacy in various headache and pain conditions, and Vagus Nerve Stimulation (VNS), which has been studied for its potential in treating chronic pain and headache disorders. Both methods offer non-invasive neuromodulation options that could be beneficial for CGH patients.

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Device

tDCS for Cervicogenic Headache

N/A

Waitlist Available

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 at baseline, immediately after treatment and at 6 and 12 weeks post treatment.

Summary

This trial uses mild electrical stimulation and physical exercises to treat people with chronic cervicogenic headaches. The electrical stimulation may help reduce pain, and the exercises aim to strengthen neck and back muscles.

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.

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.

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 at baseline, immediately after treatment and at 6 and 12 weeks post treatment.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~to be assessed at baseline, immediately after treatment and at 6 and 12 weeks post treatment.

This trial's timeline: 3 weeks for screening, Varies for treatment, and to be assessed at baseline, immediately after treatment and at 6 and 12 weeks post treatment. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Craniocervical Flexion Test (CCFT)

Feasibility of tDCS through recruitment rate, retention rate in the study, and adherence rates to both tDCS and exercise therapy.

Safety of tDCS through adverse events and transient changes in adverse effects within each tDCS session.

Secondary study objectives

Cervical Extensor Endurance Test (CEET)

Cervical Cap

Dynamometry Neck-Strength Assessment (DNSA)

+10 more

Other study objectives

Exercise diary

Headache

Side effects data

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

skin irritation

Car accident

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Transcranial Direct Current Stimulation (tDCS) modulates neuronal activity by applying a low electrical current to the scalp, which can alter cortical excitability and reduce pain perception. Physiotherapy involves physical rehabilitation techniques such as manual therapy, exercises, and posture correction to alleviate musculoskeletal issues contributing to Cervicogenic Headache (CGH). Understanding these mechanisms is crucial for CGH patients as it highlights the potential for these treatments to address both neurological and physical aspects of their condition, offering a comprehensive approach to pain management.