The Neurotrophic Effects of Lithium Carbonate Following Stroke: A Feasibility Study

NCT01112813 | Completed Phase 3 DMC

• 1 other identifier: Li-2010
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Stroke is the leading cause of adult disability and the third leading cause of death in Canada. Most stroke survivors live with residual impairments that diminish independence and quality of life. This may include vascular cognitive impairment (loss of ability to plan, think and reason) which can lead to dementia and loss of mental and functional independence. The current treatment to reduce stroke induced brain tissue injury is limited to thrombolytics (clot busters), a therapy useful only if given in the first hours following stroke. One major new approach aims to reduce cell death after stroke by targeting the ongoing tissue loss initiated by the stroke. The tissue can be maintained by interfering with later neurochemical processes that are activated by stroke, potentially through activating natural substances in the brain that help survival and growth of nerve cells ("neurotrophic" factors). The recent recognition of lithium as a neurotrophic agent has generated the first studies of lithium treatment for managing brain diseases. Clinically, lithium has now been shown to increase brain gray matter volume in bipolar patients. This effect is potentially important in stroke because gray matter loss has been implicated in the development of cognitive impairment after stroke, a result of the series of brain processes that are activated by lack of oxygen due to stroke. Our primary objective is to examine the effects of lithium on total brain gray matter volume in the post-stroke population, as measured by volumetric magnetic resonance imaging (MRI) with the hope that lithium may increase gray matter volume in post-stroke patients and lead to greater cognitive and functional rehabilitation. This study will provide valuable information on the tolerability of lithium, and its effects on clinical outcomes relevant to stroke, providing the information needed for designing a large-scale clinical trial.

Conditions

Stroke

Keywords

Stroke; lithium; MRI; gray matter

Outcome Measures

Primary Outcomes (1)

• Increase in total brain gray matter volumes

  Baseline, 2 months

Secondary Outcomes (3)

• Cognitive tasks of the Neurological Disorders and Stroke - Canadian Stroke Network's (NINDS-CSN) 30 min. battery

  Baseline, 2 months

• Serum brain-derived neurotrophic factor (BDNF) levels

  Baseline, 2 months

• Serum lithium and creatinine levels

  1-week, 4-weeks, 8-weeks

Study Arms (1)

Lithium

EXPERIMENTAL

Lithium Carbonate, 0.4-0.8 mmol/L for 2 months

Drug: Lithium Carbonate

Interventions

Lithium Carbonate DRUG

0.4-0.8 mmol/L for 2 months

Also known as: Carbolith

Lithium

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age \>40 years
• male or female
• speaks and understands English
• within 12 months post-stroke

You may not qualify if:

• subarachnoid or intracranial hemorrhage
• severe aphasia or dysphasia
• impaired level of consciousness that would preclude neuropsychiatric testing
• significant acute medical illness that may contraindicate lithium treatment(including renal dysfunction; \>106 umol/L creatinine level) affect neuropsychiatric assessments or serum BDNF results or put subject at risk from MRI procedure
• other psychiatric (exception of post-stroke depression) or neurological illnesses
• initiation of diuretic treatment
• use of antidepressant medications or initiation of antidepressant medications during the study

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M5M1P3, Canada

Location

Related Publications (1)

• Sun YR, Herrmann N, Scott CJM, Black SE, Swartz RH, Hopyan J, Lanctot KL. Lithium Carbonate in a Poststroke Population: Exploratory Analyses of Neuroanatomical and Cognitive Outcomes. J Clin Psychopharmacol. 2019 Jan/Feb;39(1):67-71. doi: 10.1097/JCP.0000000000000981.

  PMID: 30566418 RESULT

MeSH Terms

Conditions

Stroke

Interventions

Lithium Carbonate

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Carbonates; Alkalies; Inorganic Chemicals; Carbonic Acid; Carbon Compounds, Inorganic; Lithium Compounds

Study Officials

• Krista L Lanctôt, PhD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

• Nathan Herrmann, MD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2010
• First Posted: April 28, 2010
• Study Start: April 1, 2010
• Primary Completion: July 25, 2017
• Study Completion: July 25, 2017
• Last Updated: January 31, 2024

Record last verified: 2017-10

Locations

CA (1)