N/A Completed N=40 Randomized Double-blind Treatment

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

Traumatic Brain Injury

Source: ClinicalTrials.gov NCT01681589 ↗

Enrolled (actual)

Serious AEs

—

Results posted

Aug 2020

Primary outcomePrimary: Baseline Measures Before Treatment

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Baseline Measures Before Treatment	—	—
SECONDARY Post Treatment Measures to Check Improvements	—	—

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

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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. Informational only — not medical advice.