A Pilot Trial of Citicoline in Individuals With Mild Traumatic Brain Injury (mTBI)

NCT01591759 | Withdrawn Phase 2

• 1 other identifier: MCL 2011-P-002028
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This investigation will explore the impact of 8 weeks of citicoline treatment on cognitive function, clinical state and substance use in 40 individuals with mild traumatic brain injury (mTBI).

Conditions

Traumatic Brain Injury

Keywords

citicoline; cognitive function; function magnetic resonance imaging; magnetic resonance spectroscopy; diffusion tensor imaging

Outcome Measures

Primary Outcomes (1)

• Neurocognitive Assessment Changes with Citicoline Treatment

  4-Subtest Wechsler Abbreviated Scale of Intelligence (WASI) at the baseline visit only. Measures to be administered at baseline and both follow-up visits: Hopkins Verbal Learning Test-Revised (HVLT-R), Brief Visuospatial Memory Test-Revised (BVMT-R), Logical Memory (LM) Subtest of the Wechsler Memory Scale-Revised (WMS-R) and Sullivan Multiple Versions, Rey-Osterreith Complex Figure (Rey-O), Stroop Color-Word Test, Trailmaking Test A \& B, Controlled Oral Word Association Test (COWAT), Digit Span subtest of the WAIS-R, Digit Symbol Substitution Test (DSST), Wisconsin Card Sort Test (WCST), Go/No Go Test, Time Estimation Task (TET), and Facial Expressions of Emotion-Stimuli and Tests (FEEST).

  At baseline and at treatment week 4 and week 8

Secondary Outcomes (3)

• Clinical State Assessment Changes with Citicoline Treatment

  Weekly assessment & biweekly clinical scales for 8 weeks

• Functional MRI and Diffusion Tensor Imaging Changes with Citicoline Treatment

  At baseline and at treatment week 8

• Magnetic Resonance Spectroscopy Changes with Citicoline Treatment

  At baseline and at treatment week 8

Study Arms (2)

Citicoline

EXPERIMENTAL

8-week treatment of 2,000mg/day of citicoline

Drug: Citicoline

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Citicoline DRUG

2,000mg/day of citicoline taken as twice daily unit doses of 1,000 mg for the 8-week period of the clinical trial

Also known as: Citicoline Sodium

Citicoline

Placebo DRUG

Placebo arm of single-blind study

Placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subject is able to provide informed consent
• Subject is cooperative
• Subject is between 18 and 35 years of age (inclusive)
• Subject meets criteria for mTBI
• Subject has separate treating physician and is willing to provide consent for treating physician to be contacted by research team
• Subject is a native English speaker or acquired English prior to age 5

You may not qualify if:

• Serious medical illness, including diabetes, neurodegenerative disorder (i.e. multiple sclerosis, lupus, etc)
• Neurological disorder or history of serious head trauma resulting in loss of extended loss of consciousness or coma
• History of ECT treatment
• Estimated IQ \< 75
• Positive urine pregnancy test (screened on all study visits)
• Presence of a medical condition known to affect MR BOLD imaging (i.e. metabolism disorders, eating disorders, hormonal dysregulation, etc)
• Uncorrectable poor vision, as subjects must have normal or corrected-to normal vision for viewing of cognitive challenge paradigms during fMRI protocols
• Claustrophobia or metal implanted within the body, including body piercings which are not removable
• Additional MR related contraindications:
• Cardiac pacemakers
• Metal clips on blood vessels (also called stents)
• Artificial heart valve, artificial arms, hands, legs, etc.
• Brain stimulator devices
• Implanted drug pumps
• Ear or eye implants

Sponsors & Collaborators

• Mclean Hospital: lead

Study Sites (1)

McLean Hospital Brain Imaging Center

Belmont, Massachusetts, 02478-9106, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Cytidine Diphosphate Choline

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Choline; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Cytidine Diphosphate; Cytosine Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Officials

• Staci A Gruber, Ph.D.

  Mclean Hospital

  PRINCIPAL INVESTIGATOR

• Scott E Lukas, Ph.D.

  Mclean Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Cognitive and Clinical Neuroimaging Core/Assistant Professor of Psychiatry

Study Record Dates

• First Submitted: February 29, 2012
• First Posted: May 4, 2012
• Study Start: April 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: April 23, 2014

Record last verified: 2014-04

Locations

US (1)