Clinical trial NCT01365364: Dopamine Transporter Density Profiles in Patients With Periodic Limb Movements
Official title: Dopamine Transporter Density Profiles Assessed by Tc-TRODAT and SPECT in Patients With Periodic Limb Movements
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodic Limb Movements in Sleep
Keywords: PLM
dopamine
physical exercise
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
name: Associação Fundo de Incentivo à Pesquisa
First posted: 2011-06-03
Enrollment: 16
Sex: MALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

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).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Other clinical and neurological conditions,
* continuous pharmacological treatment

Primary outcomes:
measure: Dopamine Transporter Density Measurement
timeFrame: Baseline and after 5 hours of exercise effort measurements
Secondary outcomes:
measure: Exercise Effort Maximum
timeFrame: 1 week after baseline SPECT
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Centro de Estudos em Psicobiologia e Exercicio
Study officials:
affiliation: Federal University of São Paulo
name: Marco Tulio Mello, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.