Effect of electrical stimulation on the head for patients with stress after a traumatic event: controlled phase II clinical trial

Phase 2

• Conditions: Post-Traumatic Stress Disorders; S43.1

• Registration Number: RBR-2qpv74b
• Lead Sponsor: Federal University of Santa Maria (UFSM)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-12-31
• Study Start: 2021-07-01
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruitment completed
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Patients over 18 years of age diagnosed with PTSD (Post-traumatic stress disorder) without complete remission of symptoms; maintenance of the pharmacological schedule unchanged in the three weeks preceding the beginning of the proposed treatment and during the proposed treatment.

Exclusion Criteria

Patients with psychiatric indication for hospitalization; patients with severe personality disorder; presence of neurological diseases or neoplasms in activity; presence of neurodegenerative diseases; patients with metallic implants and pregnant women and nursing mothers.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
As a primary outcome, it is was evaluated the level of post-traumatic stress. It was expected to find an improvement in the level of post-traumatic stress disorder after the intervention. To assess this outcome, the Posttraumatic Stress Disorder Scale (PCL-C) - civil version was used. The scale is self-applicable. This scale was applied before the intervention, after the intervention, 30 days after the intervention and 90 days after the intervention. It is composed of 17 questions, each question has five possible answers, each answer ranging from 1 to 5 points. The sum total of points of all 17 responses ranges from 17 to 85. The meaning of values ??between 28–29 points is some symptoms of post-traumatic stress; 30–44 points, moderate to high symptoms of post-traumatic stress, 45–85 points, very high symptoms of post-traumatic stress.

Secondary Outcome Measures

Name	Time	Method
As a secondary outcome, depression was evaluated. It was expected to find an improvement in the levels of depression after the intervention. To assess this outcome, the Hamilton Depression Rating Scale (HAM-D) was used. The scale is self-applicable and the version of the scale used is the version with 17 assessment items, which is the most used version. This scale was applied before the intervention, after the intervention, 30 days after the intervention and 90 days after the intervention. The values obtained through the application of the scale are classified: 0–7, normal; 8–16, weak/minor depression; 17–23, moderate depression; and >24 points, severe depression.