Dopamine Transporter Density Profiles in Patients With Periodic Limb Movements

NCT ID: NCT01365364

Last Updated: 2011-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2010-12-31

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).

Conditions

Periodic Limb Movements in Sleep

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

PLM group

Individuals with increased periodic leg movement index (\>5)

Group Type: ACTIVE_COMPARATOR

Aerobic Physical Exercise

Intervention Type: BEHAVIORAL

All individuals were submitted to physical exercise reaching maximum effort

Aerobic Physical Exercise

Intervention Type: BEHAVIORAL

All individuals were submitted to physical exercise reaching maximum effort

Non-PLM group

Individuals with PLM index \<5

Group Type: ACTIVE_COMPARATOR

Aerobic Physical Exercise

Intervention Type: BEHAVIORAL

All individuals were submitted to physical exercise reaching maximum effort

Interventions

Aerobic Physical Exercise

All individuals were submitted to physical exercise reaching maximum effort

Intervention Type: BEHAVIORAL

Aerobic Physical Exercise

All individuals were submitted to physical exercise reaching maximum effort

Intervention Type: BEHAVIORAL

Other Intervention Names

Acute Physical Exercise: Maximal Exercise Test; Acute Physical Exercise: Maximal Exercise Test

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Other clinical and neurological conditions,
• continuous pharmacological treatment

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role: collaborator

Associação Fundo de Incentivo à Pesquisa

OTHER

Sponsor Role: collaborator

Federal University of São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Federal University of São Paulo

Principal Investigators

Marco Tulio Mello, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo

Locations

Centro de Estudos em Psicobiologia e Exercicio

São Paulo, São Paulo, Brazil

Countries

Brazil

References

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.

Reference Type: RESULT

PMID: 21358851 (View on PubMed)

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.

Reference Type: RESULT

PMID: 15517434 (View on PubMed)

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.

Reference Type: RESULT

PMID: 15223000 (View on PubMed)

Other Identifiers

CEP0546/08

Identifier Type: -

Identifier Source: org_study_id