Dopamine Transporter Density Profiles in Patients With Periodic Limb Movements (DOPATRANSPLM)

Dopamine Transporter Density Profiles Assessed by Tc-TRODAT and SPECT in Patients With Periodic Limb Movements

Restless legs syndrome and periodic limb movement (PLM)are sleep-related movement disorders and studies have shown changes in striatal dopaminergic activity in patients with these disorders. Physical exercise has been shown to improve the symptoms of restless legs syndrome and PLM, as has treatment with dopamine agonists. However, the mechanism by which physical exercise acts as a non-pharmacological treatment in improving symptoms of restless legs syndrome and PLM remains unknown. The investigators evaluated dopamine transporter density profiles in 16 sedentary patients (control and experimental - with PLM, groups) and the influence of acute physical exercise on its concentration after a maximal exercise test. Each patient underwent baseline polysomnography to evaluate sleep patterns and PLM index values. After obtaining the polysomnography baseline, the single photon emission computer tomography baseline was determined. Subsequently, the volunteers performed a maximal exercise test in the morning, followed by a single photon emission computer tomography two hours later and polysomnography that night, to assess the effect of acute physical exercise on dopamine transporter and sleep patterns. The results showed significant lower dopamine transporter baseline densities in the striatum region for the experimental group. The results also showed a significant reduction in the periodic leg movement rate in the experimental group and a significant increased percentage of stage-1 non-REM sleep in both groups after maximal exercise test. Significant differences between the groups were only observed for Stage 2 sleep and slow wave sleep. Our results show that patients with PLM had a lower dopamine transporter density in the left putamen region compared to the control group and an acute physical exercise (maximal exercise test) did not alter this profile, providing evidence that this improvement is the result of chronic physical exercise.

Study Overview

• Status: Completed
• Conditions: Periodic Limb Movements in Sleep
• Intervention / Treatment: Behavioral: Aerobic Physical Exercise

Detailed Description

Experimental Design Each volunteer (in both control and experimental groups) underwent Polysomnography (PSG) adaptation. After one week, a baseline cerebral SPECT was performed (1-3pm) and a baseline PSG was performed that night to evaluate the sleep pattern and the PLM index. Subsequently (after one week), each subject underwent a maximal exercise test (MET) in the morning (11am to 1pm) after which SPECT examination was performed in the afternoon (1-3 pm). A PSG was then performed that night to evaluate the effect of acute exercise on DAT density and sleep pattern (Figure 1).

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 04020-050
    • Centro de Estudos em Psicobiologia e Exercicio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• With and without PLM,
• no other health problems,
• sedentary

Exclusion Criteria:

• Other clinical and neurological conditions,
• continuous pharmacological treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: PLM group; Individuals with increased periodic leg movement index (>5)	Behavioral: Aerobic Physical Exercise; All individuals were submitted to physical exercise reaching maximum effort; Other Names: Acute Physical Exercise: Maximal Exercise Test
ACTIVE_COMPARATOR: Non-PLM group; Individuals with PLM index <5	Behavioral: Aerobic Physical Exercise; All individuals were submitted to physical exercise reaching maximum effort; Other Names: Acute Physical Exercise: Maximal Exercise Test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dopamine Transporter Density Measurement	Dopamine Transporter Density Measurement assessed by SPECT using TRODAT-1	Baseline and after 5 hours of exercise effort measurements

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exercise Effort Maximum	Exercise Effort VO2 maximum measurement	1 week after baseline SPECT

Collaborators and Investigators

• Sponsor: Federal University of São Paulo
• Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo; Associação Fundo de Incentivo à Pesquisa

Publications and helpful links

General Publications

• Earley CJ, Kuwabara H, Wong DF, Gamaldo C, Salas R, Brasic J, Ravert HT, Dannals RF, Allen RP. The dopamine transporter is decreased in the striatum of subjects with restless legs syndrome. Sleep. 2011 Mar 1;34(3):341-7. doi: 10.1093/sleep/34.3.341.
• Mrowka M, Jobges M, Berding G, Schimke N, Shing M, Odin P. Computerized movement analysis and beta-CIT-SPECT in patients with restless legs syndrome. J Neural Transm (Vienna). 2005 May;112(5):693-701. doi: 10.1007/s00702-004-0217-9. Epub 2004 Oct 27.
• Wetter TC, Eisensehr I, Trenkwalder C. Functional neuroimaging studies in restless legs syndrome. Sleep Med. 2004 Jul;5(4):401-6. doi: 10.1016/j.sleep.2004.01.009.

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (ACTUAL): October 1, 2010
• Study Completion (ACTUAL): December 1, 2010

Study Registration Dates

• First Submitted: May 16, 2011
• First Submitted That Met QC Criteria: June 2, 2011
• First Posted (ESTIMATE): June 3, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): June 3, 2011
• Last Update Submitted That Met QC Criteria: June 2, 2011
• Last Verified: May 1, 2011

More Information

Terms related to this study

• Keywords: physical exercise; dopamine; PLM
• Other Study ID Numbers: CEP0546/08