Status:
TERMINATED
TMS Measures of Plasticity and Excitatory/Inhibitory Ratio as Biomarkers: R-baclofen Effects in Normal Volunteers
Lead Sponsor:
Gonzalez-Heydrich, Joseph, M.D.
Collaborating Sponsors:
Boston Children's Hospital
Seaside Therapeutics, Inc.
Conditions:
Autism
Eligibility:
All Genders
18-30 years
Phase:
PHASE1
Brief Summary
Our overall objective is to apply Transcranial Magnetic Stimulation (TMS) to develop measures of human synaptic plasticity and of brain excitatory:inhibitory ratio (E:I ratio), which we propose as nov...
Detailed Description
The design is a double-blind placebo controlled 5 way crossover trial of a single dose each of placebo x 2 (0 mg), 3, 10, and 25 mg of R-baclofen followed by plasma levels at 0, 30, 60, 90, and 140 mi...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Age: 18-30
- IQ: higher than 85
- Normal physical examination
- Exclusion Criteria
- significant medical problems
- ongoing medications
- All female participants are required to have a negative pregnancy test
Exclusion
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01172509
Start Date
October 1 2010
End Date
July 1 2012
Last Update
August 21 2015
Active Locations (1)
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1
Berenson-Allen Center for Noninvansive Brain Stimulation Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215