Comparison Between Transcranial Stimulation Protocols With Continuous Current in the Chronic Migraine

Chronic Migraine Clinical Trial

— NEUROMIG  

Official title:

Comparison Between Stimulation Transcranial Protocols With Continuous Current in the Chronic Migraine: Clinical Trial, Triple-blind, Placebo-controlled

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03414203
• Other study ID #: NEUROMIG
• Status: Completed
• Phase: N/A
• Start date: August 14, 2017
• Est. completion date: February 16, 2018

Study information

• Verified date: August 2019
• Source: Federal University of Paraíba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to compare the effects of transcranial direct current stimulation on the clinical and cognitive function in patients with chronic migraine.

Description:

The patients will be randomized into 1 of 3 groups: active tDCS for 15 minutes, active tDCS for 15 minutes, with an interval of 20 minutes and more 15 minutes os stimulation, sham tDCS for 15 minutes. The tDCS will be applied for 10 days over 2 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: February 16, 2018
• Est. primary completion date: February 5, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

• females

• clinical diagnosis of chronic migraine according to the International Classification of Headaches Disorders (ICHD-3 beta).

Exclusion Criteria:

• headache attributable to some pathological condition, associated neurologic or neuropsychiatric disease

• use of central nervous system modulating drugs

• pregnancy

• metallic head implants

• use of a cardiac pacemaker

Related Conditions & MeSH terms

• Chronic Migraine
• Migraine Disorders

Intervention

Other:
• tDCS
Transcranial Current Stimulation equipment consists of an ammeter (measured with current intensity), a potentiometer (voltage controller between the electrodes), a generator (two 9-volt batteries) and two electrodes (anode and cathode). The direct low-amplitude currents released by the electrodes reach the cortex and modify the neuronal potentials.

Locations

Country	Name	City	State
Brazil	Federal University of Paraiba	João Pessoa	Paraiba

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Paraíba

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Migraine Disability Assessment - MIDAS	Change in perform activities of daily living associate to migraine assessed on the Migraine Disability Assessment - MIDAS.	"before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"
Secondary	Headache Impact Test - HIT-6	Change in quality of life associate to migraine assessed on the Headache Impact Test-6 (HIT-6)	"before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"
Secondary	Wechsler Intelligence Scale Letters	Change in cognitive ability assessed on the Wechsler Adult Intelligence Scale Letters	"before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"
Secondary	Wechsler Intelligence Scale Numbers Test	Change in cognitive ability assessed on the Wechsler Adult Intelligence Scale Numbers Test	"before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"
Secondary	Hayling's Test Hayling's Test	Change in operational memory assessed on the Hayling's Test Evaluate operational memory	"before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"
Secondary	Trail Making Test part B	Change in executive functions assessed on the Trail Making Test part B	"before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"
Secondary	Salthouse Visual Patterns and Lyrics	Change in visual processing speed assessed on the Salthouse Visual Patterns and Lyrics	"before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"
Secondary	Nine Hole Peg Test	Change in the motor processing speed assessed on the Nine Hole Peg Test	"before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"
Secondary	Paced Auditory Serial Addition Task	Change in selective attention assessed on the Paced Auditory Serial Addition Task	"before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"
Secondary	Concentrated Attention Test	Change in selective attention assessed on the Concentrated Attention Test	"before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"
Secondary	Visual Attention Test (Attention Matrices)	Change in selective attention assessed on the Visual Attention Test (Attention Matrices)	"before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"
Secondary	Montreal Cognitive Assessment	Change in cognition assessed on the Montreal Cognitive Assessment	"before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"
Secondary	Side Effects Questionnaire	adverse effects assessment	"every day for up to 2 weeks"