N/A
N=40
Relationship Between Attention and Emotional Regulation Post-Traumatic Brain Injury (TBI)
Traumatic Brain Injury
Bottom Line
View on ClinicalTrials.gov: NCT01681589 ↗Enrolled (actual)
40
Serious AEs
—
Results posted
Aug 2020
Primary outcome: Primary: Baseline Measures Before Treatment
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Transcranial Direct Current Stimulator (TDCS) (Device); Control Group (Device); Healthy Control Group (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Baseline Measures Before Treatment |
— | — |
| SECONDARY Post Treatment Measures to Check Improvements |
— | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01681589). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.