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

NCT ID: NCT03347955

Last Updated: 2017-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

1994-11-30

Study Completion Date

1999-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Parkinson Disease Surgery

Keywords

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placebo effect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
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.

Study Groups

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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.

Group Type EXPERIMENTAL

Neural implantation group

Intervention Type PROCEDURE

Cultured mesencephalic tissue from four embryos was implanted into the putamen bilaterally for those receiving the implant

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.

Group Type SHAM_COMPARATOR

Sham surgery

Intervention Type PROCEDURE

Steel frame affixed to head and four burr holes drilled into forehead of sham surgery patients

Interventions

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Neural implantation group

Cultured mesencephalic tissue from four embryos was implanted into the putamen bilaterally for those receiving the implant

Intervention Type PROCEDURE

Sham surgery

Steel frame affixed to head and four burr holes drilled into forehead of sham surgery patients

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Denver

OTHER

Sponsor Role lead

Responsible Party

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Cynthia McRae, PhD

Research Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cynthia McRae, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Denver

Stanley Fahn, MD

Role: STUDY_CHAIR

Neurological Institute, Columbia University

Curt Freed, MD

Role: STUDY_DIRECTOR

University of Colorado Health Sciences

Locations

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Morgridge College of Education, University of Denver

Denver, Colorado, United States

Site Status

Countries

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United States

References

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McRae C, Cherin E, Yamazaki TG, Diem G, Vo AH, Russell D, Ellgring JH, Fahn S, Greene P, Dillon S, Winfield H, Bjugstad KB, Freed CR. Effects of perceived treatment on quality of life and medical outcomes in a double-blind placebo surgery trial. Arch Gen Psychiatry. 2004 Apr;61(4):412-20. doi: 10.1001/archpsyc.61.4.412.

Reference Type BACKGROUND
PMID: 15066900 (View on PubMed)

Freed CR, Greene PE, Breeze RE, Tsai WY, DuMouchel W, Kao R, Dillon S, Winfield H, Culver S, Trojanowski JQ, Eidelberg D, Fahn S. Transplantation of embryonic dopamine neurons for severe Parkinson's disease. N Engl J Med. 2001 Mar 8;344(10):710-9. doi: 10.1056/NEJM200103083441002.

Reference Type RESULT
PMID: 11236774 (View on PubMed)

Related Links

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https://www.ncbi.nlm.nih.gov/pubmed?term=%22Archives+of+general+psychiatry%22%5BJour%5D+AND+2004%5Bpdat%5D+AND+McRae+C%5Bauthor%5D&cmd=detailssearch

Quality of life report on double-blind fetal transplant surgery for treatment of Parkinsons disease

https://www.ncbi.nlm.nih.gov/pubmed?term=%22The+New+England+journal+of+medicine%22%5BJour%5D+AND+344%5Bvolume%5D+AND+2001%5Bpdat%5D+AND+Freed%5Bfirst+author%5D+AND+Transplantation&TransSchema=title&cmd=detailssearch

Neurological and medical results of double-blind fetal transplant surgery as treatment for Parkinson's disease

Other Identifiers

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R29NS032009-05

Identifier Type: NIH

Identifier Source: org_study_id

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