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Trial record 27 of 33575 for:    Placebo AND placebo effect

Double-blind Placebo Surgery Trial for Treatment of Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT03347955
Recruitment Status : Completed
First Posted : November 20, 2017
Last Update Posted : November 20, 2017
Sponsor:
Information provided by (Responsible Party):
Cynthia McRae, PhD, University of Denver

Brief Summary:
A double-blind sham surgery-controlled trial was developed to determine the effectiveness of implantation of human embryonic dopamine neurons into the putamen of patients with advanced Parkinson's disease (PD), with half the patients receiving the implant (n = 20) and half receiving sham surgery (n = 20). The blind was maintained for 12 months before participants were told which surgery they received, at which time those receiving sham surgery could request the implant surgery.

Condition or disease Intervention/treatment Phase
Parkinson Disease Surgery Procedure: Neural implantation group Procedure: Sham surgery Not Applicable

Detailed Description:
A double-blind sham surgery-controlled trial was conducted to determine the effectiveness of implantation of human embryonic dopamine neurons into the putamen of patients with advanced Parkinson's disease (PD), with half the patients receiving the implant (n = 20) and half receiving sham surgery (n = 20). The goals were to determine whether the cells survived and led to improvement of symptoms, and to examine the effect of age on results of the implantation. Quality of life of participants and care partners was also examined at each of the assessment periods (baseline, 4, 8 and 12 months). The blind was maintained for 12 months.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: In this double-blind study, 20 participants were randomly assigned to the treatment group and 20 to the sham surgery group with the blind being maintained for 12 months.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: All of the above were "masked." Only the neurosurgeon (Dr. Breeze) who did the implant and the person in charge of random assignment were aware of which participant received which treatment.
Primary Purpose: Treatment
Official Title: Transplantation of Embryonic Dopamine Neurons for Treatment of Parkinson's Disease: Double-blind Placebo Surgery Trial
Actual Study Start Date : November 1994
Actual Primary Completion Date : February 1999
Actual Study Completion Date : February 1999

Resource links provided by the National Library of Medicine

Drug Information available for: Dopamine

Arm Intervention/treatment
Experimental: Neural implantation group
Human embryonic dopamine neurons were implanted into brains of half the randomized participants (n = 20). Participants were evaluated at baseline, 4, 8, and 12 months after surgery.
Procedure: Neural implantation group
Cultured mesencephalic tissue from four embryos was implanted into the putamen bilaterally for those receiving the implant

Sham Comparator: Sham Surgery group
This group (n = 20) received sham surgery with a steel frame affixed to their heads and four burr holes drilled into their foreheads without crossing the blood/brain barrier. Participants were assessed at baseline, 4, 8, and 12 months after surgery.
Procedure: Sham surgery
Steel frame affixed to head and four burr holes drilled into forehead of sham surgery patients




Primary Outcome Measures :
  1. Global Rating Scale [ Time Frame: Same scale was administered 7 days after surgery and prior to follow-up visits at Columbia at 4, 8, and 12 months after surgery and before the blind was lifted. ]
    one item scale where participants marked their answer on a scale ranging from -3 (much worse since surgery) to 0 (no change) to +3 (much improved since surgery)



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with Parkinson's disease (PD) for more than 7 years, improvement in response to levodopa, Positive Emission Tomography scan compatible with presence of PD, improvement of at least 33% on UPDRS after first morning dose of levodopa

Exclusion Criteria:

  • Mini-mental status exam score of less than 24, hallucinations during levodopa therapy, epilepsy, previous brain surgery, severe depression, another neurologic disorder, cardiovascular disease, and medical contraindication of surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03347955


Locations
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United States, Colorado
Morgridge College of Education, University of Denver
Denver, Colorado, United States, 80208
Sponsors and Collaborators
University of Denver
Investigators
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Principal Investigator: Cynthia McRae, PhD University of Denver
Study Chair: Stanley Fahn, MD Neurological Institute, Columbia University
Study Director: Curt Freed, MD University of Colorado Health Sciences

Additional Information:
Publications of Results:
Other Publications:
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Responsible Party: Cynthia McRae, PhD, Research Professor, University of Denver
ClinicalTrials.gov Identifier: NCT03347955     History of Changes
Other Study ID Numbers: R29NS032009-05 ( U.S. NIH Grant/Contract )
First Posted: November 20, 2017    Key Record Dates
Last Update Posted: November 20, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Cynthia McRae, PhD, University of Denver:
placebo effect

Additional relevant MeSH terms:
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Physiological Effects of Drugs
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Dopamine
Cardiotonic Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents