Bilateral DLPC tDCS in Drug-resistant Migraine

Migraine Clinical Trial

Official title:

Bilateral DLPC tDCS: a New Potential Neuromodulatory Strategy in Drug-resistant Migraine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06079801
• Other study ID #: ClinicaIN01
• Status: Completed
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: August 31, 2023

Study information

• Verified date: October 2023
• Source: Clínica de Intervención en Neurociencias
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to study and describe the effects of bilateral tDCS applied to dorso-lateral-prefrontal cortex (DLPC) in patients with drug-resistant migraine in terms of reduction in frequency of pain, impact of pain in daily life, quality of sleep and psychological measures. We finally planned to include high frequency and chronic migraine patients.

The main questions it aims to answer are:

• Will bilateral DLPC tDCS be feasible, well tolerated and safe in drug resistant migraine patients?

• Will bilateral DLPC tDCS be effective in reducing pain frequency, intensity and its impact in daily life activities?

• Will bilateral DLPC tDCS be effective in ameliorating sleep and psychological associated symptoms?

• Will bilateral DLPC tDCS be such effective in reducing pain frequency, intensity and its impact in daily life activities as anti-CGRP treatments?

Participants will undergo 2 tDCS sessions daily for 2 consecutive weeks. Patients will be blinded to treatment and will be divided in two groups (real vs placebo). A third group of patients, age-matched to the other two, will undergo anti-CGRP treatment. Patients will be asked to complete Patient-Reported Outcomes (PROMs) scales at baseline, one week after the end of the treatment and at 6 months after the end of the treatment.

Researchers (blinded to the treatment) will compare the group that underwent real tDCS treatment vs the one that underwent placebo tDCS vs the one that underwent anti-CGRP drugs to see if bilateral DLPC tDCS is effective in reducing migraine frequency, intensity and impact and if bilateral DLPC tDCS is such effective as anti-CGRP treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: August 31, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• diagnosis of high-frequency and/or chronic migraines, according to the diagnostic criteria of the ICHD-III,

• failure to more than 3 preventive drugs

• stable pharmacological treatment (> 6 months without changes),

• absence of other neurological or medical pathological conditions,

• written informed consent.

Exclusion Criteria:

• seizures

• significant cognitive impairment that prevents following orders and understanding instructions (Mini-Mental State Examination < 23)

• pregnancy

• aphasia or limitations in communication,

• metallic cranial implants

• another neurological or psychiatric pathology

• diagnosis of another type of migraine.

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Device:
• Transcranial direct current stimulation (tDCS)
TDCS was delivered by a DC-Stimulator (Newronika, Italy) over both DLPC. The electrodes (35 cm2) were soaked in 0.9% NaCl. The anode was positioned on the left dorsolateral prefrontal cortex and the cathode on the right dorsolateral prefrontal cortex.

Drug:
• anti-CGRP-mAbs
CGRP-mAbs have been the first target-driven treatment to be approved for migraine prevention. Their efficacy and safety have been demonstrated in randomized controlled trials (RCT) as well as, in real-world evidence (RWE) studies

Locations

Country	Name	City	State
Spain	Clinica de Intervencion en Neurociencias	Talavera De La Reina	Toledo

Sponsors (1)

Lead Sponsor	Collaborator
Clínica de Intervención en Neurociencias

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Migraine attacks monthly frequency	Patients will report migraine monthly frequency for the 3 different time-points	baseline, 2 weeks after the end of the treatment, 6 months
Primary	Headache Impact Test (HIT-6) score	HIT-6 is a tool used to measure the impact headaches have on patient's ability to function on the job, at school, at home and in social situations.	baseline, 2 weeks after the end of the treatment, 6 months
Primary	Pain killer drugs monthly taken	Patients will report pain-killer drugs taken during a month for the 3 different time-points	baseline, 2 weeks after the end of the treatment, 6 months
Secondary	The Pittsburgh Sleep Quality Index (PSQI)	PSQI is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating 7 components that produce one global score, and takes 5-10 minutes to complete.	baseline, 2 weeks after the end of the treatment, 6 months
Secondary	Brief Symptom Inventory (BSI)	The Brief Symptom Inventory (BSI) consists of 53 items covering nine symptom dimensions: Somatization, Obsession-Compulsion, Interpersonal Sensitivity, Depression, Anxiety, Hostility, Phobic anxiety, Paranoid ideation and Psychoticism; and three global indices of distress: Global Severity Index, Positive Symptom Distress Index, and Positive Symptom Total. The global indices measure current or past level of symptomatology, intensity of symptoms, and number of reported symptoms, respectively.	baseline, 2 weeks after the end of the treatment, 6 months