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

University of Denver

Status: Completed

Conditions: Surgery; Parkinson Disease

Treatments: Procedure: Sham surgery; Procedure: Neural implantation group

Study type: Interventional

Funder types: Other

Identifiers

NCT03347955

R29NS032009-05

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups

Neural implantation group

Experimental group

Description:

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.

Treatment:

Procedure: Neural implantation group

Sham Surgery group

Sham Comparator group

Description:

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.

Treatment:

Procedure: Sham surgery