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

Effect of Transcranial Stimulation by Continuous Current in patients with Post-Traumatic Stress Disorder

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

REBEC

Registry ID

RBR-2qpv74b

Enrollment

Unknown

Registered

2021-07-01

Start date

2015-03-01

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-Traumatic Stress Disorders

Interventions

Intervention will be carried out in a maximum of 10 research subjects. tDCS sessions were performed with two electrodes positioned as follows: the cathode on the right dorsolateral prefrontal cortex a

E02.331.750

F04.570.200.791

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Eligibility

Age

18 Years to No maximum

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Brazil

Contacts

Public ContactFabio;Tiango Alves;Ribeiro

;

falves@accamargo.com.br;tiangoribeiro@gmail.com+55-11-2189-5130;+55 55 991275091

Outcome results

None listed

Source: REBEC (via WHO ICTRP)