Relationship Between Attention and Emotional Regulation Post-Traumatic Brain Injury (TBI)

NYU Langone Health

Status: Completed

Conditions: Traumatic Brain Injury

Treatments: Device: Control Group; Other: Healthy Control Group; Device: Transcranial Direct Current Stimulator (TDCS)

Study type: Interventional

Funder types: Other

Identifiers

NCT01681589

11-00685

Details and patient eligibility

About

The purpose of this pilot study is to investigate the relationship between attention and emotional function post-Traumatic Brain Injury (TBI) in an effort to better understand the cognitive mechanisms of emotional processing in patients with TBI, and explore novel treatment strategies to improve emotional regulation using with transcranial direct current stimulation (tDCS) to modulate activity in the dysfunctional prefrontal-limbic circuits.

Full description

Thirty (30) individuals status post TBI with complaints of emotional dysfunction 6 months post-brain injury and Fifteen (15) healthy controls will participate in the study. The experimental group will receive active tDCS for 20 minutes and computerized cognitive training twice a week for 30-45 minutes for 6 weeks as described below. The control group will receive sham-tDCS 20 minutes and computerized cognitive training for 30-45 minutes twice a week for 6 weeks (12 training sessions). The sham group will not receive real tDCS after completion of the study.

Enrollment: 40 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Brain Injury at least 6 months prior
• Family or self-identification of cognitive or emotional difficulties
• Unchanged and stabilized medical treatment in the three weeks prior to the screening

Exclusion criteria

• Any social or medical problem that precludes completion of the protocol.
• Presence of focal motor deficits in the upper extremities.
• Comorbid psychiatric disease such as schizophrenia, or active substance abusers (except nicotine).
• History of craniectomy, active infection, or seizure activity beyond 1 week post-TBI.
• Complicating medical problems such as uncontrolled hypertension, diabetes with signs of neuropathy, and previous neurological illness such as head trauma, prior stroke, epilepsy or demyelinating disease, implanted neuromodulatory or electronic device, metal in head
• Pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

40 participants in 3 patient groups

Control Group

Sham Comparator group

Description:

The control group will receive sham-tDCS and computerized cognitive training also twice a week for 20 minutes for 6 weeks (12 training sessions).

Treatment:

Device: Control Group

Transcranial Direct Current Stimulator (TDCS)

Experimental group

Description:

The experimental group will receive active tDCS for 20 minutes and computerized cognitive training twice a week for 30 minutes for 6 weeks.

Treatment:

Device: Transcranial Direct Current Stimulator (TDCS)

Healthy Control Group

Other group

Description:

Fifteen (15) healthy control subjects will participate.

Treatment:

Other: Healthy Control Group